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Trial registered on ANZCTR
Registration number
ACTRN12624001123538
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
18/09/2024
Date last updated
18/09/2024
Date data sharing statement initially provided
18/09/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Phase 1 Trial of ITM-22 in Patients with Prostate-Specific Membrane Antigen (PSMA)-positive Progressive Metastatic Castration Resistant Prostate Cancer
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Scientific title
A Multicentre, Open-label, Interventional, Repeated Dose Escalation/De-escalation Phase I Trial to Determine the Optimal Biological Dose, and Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Actinium (225Ac) Ibu-DAB-PSMA for the Treatment of PSMA-positive Progressive Metastatic Castration Resistant Prostate Cancer
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Secondary ID [1]
312446
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ITM-2221-01CT
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Progressive metastatic castration resistant prostate cancer (mCRPC)
334275
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Condition category
Condition code
Cancer
330936
330936
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0
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment with radiotherapeutic Actinium (225Ac) Ibu-DAB-PSMA (ITM-22) will be carried out in 2 phases.
Phase I part of the trial is to determine the actinium (225Ac) Ibu-DAB-PSMA optimal biological dose based on the number of evaluable participants reaching a PSA response (a PSA decrease of =30%) and the number of evaluable participants experiencing safety limiting events within 8 weeks from the first dose.
The treatment with actinium (225Ac) Ibu-DAB-PSMA will consist of a maximum of 12 MBq of cumulative injected activity administered as a slow bolus injection at different dose levels and a varying number of treatment cycles. The Nuclear Medicine Physician will administer the intervention in consultation with the Medical Oncologist.
Each cycle, regardless of the dose activity, will be administered at 8-week intervals (authorised window: not less than 6 weeks and up to 13 weeks to allow toxicity recovery and investigational medicinal product (IMP) ordering) or until diagnosis of disease progression as determined by the Investigator, death, intolerable toxicity, trial treatment consent withdrawal or lost to follow-up, whichever occurs earlier. Each set of evaluable participants will consist of 3 participants who received the same DL at a time.
The trial will follow an adaptive Bayesian Optimal Interval design. Actinium (225Ac) Ibu-DAB-PSMA dose escalation and de-escalation procedure will include:
• Dose Level 1 (DL1): receiving 2 ± 0.2 MBq, for Cycles 1 to 6, total duration 48 weeks
• Dose Level 2 (DL2): receiving 4 ± 0.4 MBq, for Cycles 1 to 3, total duration 24 weeks
• Dose Level 3 (DL3): receiving 6 ± 0.6 MBq, for Cycles 1 to 2, total duration 16 weeks
In the Phase I part of the trial using BOIN12 designs, safety limiting events (SLEs) and prostate-specific antigen (PSA) response will be analysed to inform the DMC on the toxicity and efficacy profile presented in each Dose Level (DL). The proportion of participants at each DL with toxicity and efficacy outcomes will be used to determine the desirability of each DL.
A Data Monitoring Committee (DMC) will be responsible for monitoring the safety of study participants. Frequency of DMC meetings will depend on recruitment speed. DMC meetings will take place after each cohort (3 pts) is dosed in Phase I (after Cycle 1). The DMC will review safety, efficacy and dosimetry data, the relevant information on safety profiles of the IMP, SLEs and PSA response and the toxicity and efficacy profile presented in each DL.
Once a dose level maximum has been continually established (12 participants per dose level), or the maximum sample size has been reached (24 participants overall); the two doses with the highest desirability scores will be carried across into a Phase II of the trial.
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Intervention code [1]
328952
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Treatment: Drugs
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Comparator / control treatment
There is no comparator group for this study.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Phase 1 - Determine the actinium (225Ac) Ibu-DAB-PSMA optimal biological dose.
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Assessment method [1]
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Actinium (225Ac) Ibu-DAB-PSMA optimal biological dose will be based on the number of valuable participants reaching a PSA response and the number of evaluable participants experiencing safety limiting events (SLEs).
The following events that are related to the investigational drug including any death not related to either the underlying disease or extraneous causes will be considered SLEs.
Non-Haematologic Toxicity:
1. Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 xerostomia with severe oral intake alterations for >7 consecutive days
2. Renal impairment, defined as one of the following toxicities for >7 consecutive days:
-CTCAE Grade 2 serum creatinine increased
-CTCAE Grade 2 eGFR decreased
-Serum creatinine increased =40% from baseline
-eGFR decreased =40% from baseline
3. Hepatic impairment defined as one of the following:
-ALT or AST >8 x ULN
-ALT or AST >5 x ULN for more than 2 weeks
-ALT or AST >3 x ULN and total bilirubin level >2 x ULN or international normalised ratio >1.5)
-ALT or AST >3.0 x ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (>5%)
-AST or ALT >3.0 x ULN combined with total bilirubin >2.0 x ULN to =3x ULN without evidence of cholestasis, also referred to as Hy’s law cases (for participants with normal baseline ALT and AST and total bilirubin value)
-AST or ALT >3.0 x baseline OR >8.0 x ULN, whichever is lower, combined with total bilirubin >2.0 x baseline AND >2.0 x ULN to =3.0 x ULN (for participants with
4. CTCAE Grade 3 or higher events of any duration, with the following exceptions:
-CTCAE Grade 3 fatigue lasting less than 7 consecutive days
-CTCAE Grade 3 vomiting or CTCAE Grade 3 nausea lasting less than 72 hours
-CTCAE Grade 3 diarrhoea lasting less than 72 hours
-CTCAE Grade 3 electrolyte abnormality that lasts up to 72 hours, is not clinically complicated, and resolves spontaneously or responds to conventional medical interventions
-CTCAE Grade 3 or higher amylase or lipase that is not associated with symptoms or clinical manifestations of pancreatitis
-CTCAE Grade 3 tumour pain controlled by use of optimal analgesia
Haematologic Toxicity:
-CTCAE Grade 3 thrombocytopenia for more than 7 days or with significant bleeding
-CTCAE Grade 3 neutropenia for more than 14 days
-Anaemia of any grade that requires transfusion
-Febrile neutropenia
-CTCAE Grade 4 anaemia, neutropenia, or thrombocytopenia of any duration
Any other Grade =2 toxicity which is still ongoing at week 8 from the last treatment dose and resulting in a >14-day treatment delay.
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Timepoint [1]
338703
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Number of evaluable participants reaching prostate-specific antigen (PSA) decline of =30% within 8 weeks from the first dose.
-PSA efficacy assessments are every 4 ± 1 week from the first IMP administration during treatment period and then after end of last treatment (EOLT) every 12 ± 2 weeks until documented PSA progression (PSA increased greater than or equal to 25% and greater than or equal to 2 ng/mL over nadir on 2 consecutive assessments measured at least 3 weeks apart) or EOT, whichever occurs earlier (can be coupled with other visits when possible), unless the participant started a new anti-cancer treatment.
Number of evaluable participants experiencing safety limiting events (predefined events considered related to the investigational drug, including non-haematologic and haematologic toxicities, and also any death not related to either the underlying disease or extraneous causes) within 8 weeks from the first dose.
-SLEs safety labs assessments (haematology and biochemistry parameters) are to be performed every 2 ± 1 weeks from first treatment until EOLT.
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Secondary outcome [1]
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Phase 1 - To further characterise and confirm the safety and tolerability of actinium (225Ac) Ibu-DAB-PSMA.
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Assessment method [1]
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Adverse event rates (including grade, severity and dose modifications), Safety laboratory parameters, Vital signs, Xerostomia questionnaire.
Possible side effects:
•Dry mouth
•Decrease in the number of red blood cells (anaemia)
•Decrease in the number of white blood cells (leukopenia, neutropenia)
•Decrease in the number of platelets (thrombocytopenia)
•Gastrointestinal symptoms: nausea, vomiting, diarrhoea and constipation
•Decreased kidney function
•Decreased appetite, anorexia and weight loss
•Fatigue
•Pain
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Timepoint [1]
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Information about AEs and SAEs will be collected from signing the Informed Consent Form (ICF) until 50 days (5 half-lives) following the last dose of trial treatment or until end of last treatment visit, whichever occurs later.
The occurrence of AEs will be questioned/collected from the participant at each visit during the trial. AEs also may be detected when they are volunteered by the participant during or between visits or through physical examination findings, laboratory test findings, or other assessments, including relevant patient-oriented outcome questionnaires (e.g., xerostomia or pain questionnaires).
Safety labs and vital signs will be collected at screening, during treatment period until end of trial.
Xerostomia questionnaire will be performed every 4 ± 1 weeks during treatment until end of last treatment and then after end of last treatment every 12 ± 2 weeks during the long-term follow-up, until end of trial.
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Secondary outcome [2]
437078
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of rPFS and rPFS rates.
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Assessment method [2]
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As per Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
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Timepoint [2]
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rPFS and rPFS rates are analysed at 3, 5, 7, 10 and 13 months starting after first IMP administration.
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Secondary outcome [3]
439495
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of objective response rates (ORR).
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Assessment method [3]
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According to Response Evaluation Criteria in prostate specific membrane antigen-positron
emission tomography/computed tomography (RECIP 1.0).
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Timepoint [3]
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At 3, 5, 7, 10 and 13 months starting after first IMP administration.
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Secondary outcome [4]
439496
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of PSA decrease.
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Assessment method [4]
439496
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Blood based PSA percent change (continuous and rate of = 50% PSA decrease).
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Timepoint [4]
439496
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At 3, 5, 7, 10 and 13 months starting after first IMP administration.
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Secondary outcome [5]
439497
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of duration of responses.
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Assessment method [5]
439497
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PSMA PET/CT imaging analysed according to RECIP 1.0 and blood-based PSA assessments (composite outcome).
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Timepoint [5]
439497
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PSMA PET/CT first tumour assessment (12 ± 2 weeks) and at every 8 ± 1 weeks until week 28. After week 28, the assessments will be every 12 ± 2 weeks until documented RECIP 1.0 disease progression or EOT, whichever occurs earlier, unless the participant started a new anti-cancer treatment.
PSA assessments will be performed every 4 ± 1 weeks from first IMP administration during treatment until EOLT and then after EOLT every 12 ± 2 weeks during the long-term follow-up.
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Secondary outcome [6]
439498
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of time to progressions by morphological imaging.
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Assessment method [6]
439498
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As per Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
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Timepoint [6]
439498
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Morphological imaging first tumour assessment at 12 ± 2 weeks and at every 8 ± 1 weeks until week 28. After week 28, the assessments will be every 12 ± 2 weeks. Follow-up assessments should be continued until first radiographical disease progression is documented according to PCWG3 criteria or until EOT, whichever occurs earlier, unless the participant started a new anti-cancer treatment.
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Secondary outcome [7]
439499
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.
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Assessment method [7]
439499
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The FACT-P questionnaire will be used for the assessment of the general health state. They will not be considered for the diagnosis of progression or symptomatic tumour response.
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Timepoint [7]
439499
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Completed by participants every 4 ± 1 weeks during the treatment period until EOLT visit and then every 12 ± 2 weeks during the follow-up (until EOT visit).
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Secondary outcome [8]
439500
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of analgesics consumption.
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Assessment method [8]
439500
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As part of study visit discussion with the investigator. Data collected is recorded in patient medical records.
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Timepoint [8]
439500
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Up to 30 days prior to enrolment and continuously until EOT.
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Secondary outcome [9]
439503
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of time to first symptomatic skeletal event (SSE).
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Assessment method [9]
439503
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According to PCWG3. PCWG3 advises reporting skeletal events that include only symptomatic events of clear clinical significance such as clinical pathologic fractures, spinal cord compression, and surgery or radiation therapy to bone.
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Timepoint [9]
439503
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From signing the ICF and continuously until EOT.
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Secondary outcome [10]
439686
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of time to progressions in PSA levels.
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Assessment method [10]
439686
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Blood-based PSA assessment.
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Timepoint [10]
439686
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PSA assessments will be performed every 4 ± 1 weeks from first IMP administration during treatment until EOLT and then after EOLT every 12 ± 2 weeks during the long-term follow-up.
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Secondary outcome [11]
439687
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of time to progressions by PSMA PET/CT imaging.
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Assessment method [11]
439687
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As per RECIP 1.0.
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Timepoint [11]
439687
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PSMA PET/CT imaging first tumour assessment at 12 ± 2 weeks and at every 8 ± 1 weeks until week 28. After week 28, the assessments will be every 12 ± 2 weeks until documented RECIP 1.0 disease progression or EOT, whichever occurs earlier, unless the participant started a new anti-cancer treatment.
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Secondary outcome [12]
439688
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Phase 1 - Evaluate preliminary efficacy signals of actinium (225Ac) Ibu-DAB-PSMA in the treatment of progressive mCRPC by analysis of Brief Pain Inventory – Short Form (BPI-SF) questionnaire.
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Assessment method [12]
439688
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The BPI-SF questionnaire will be used for the assessment of the severity of pain and its
impact on functioning. It will not be considered for the diagnosis of progression or symptomatic.
tumour response.
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Timepoint [12]
439688
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Completed by participants every 4 ± 1 weeks during the treatment period until EOLT visit and then every 12 ± 2 weeks during the follow-up (until EOT visit).
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Secondary outcome [13]
439689
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Phase 1 Exploratory - Assess pharmacokinetics (PK) and dosimetry of actinium (225Ac) Ibu-DAB-PSMA.
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Assessment method [13]
439689
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-Blood and urine samples will be collected to determine of the amount of radioactivity in the blood and urine during treatment. This will be obtained by measuring the activity of blood and urine samples using a gamma counter.
-Whole body (WB) anterior and posterior planar scans for evaluation of biodistribution at post-infusion and abdominal SPECT/CT scans will be collected.
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Timepoint [13]
439689
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Participants will undergo dosimetry and PK assessments using imaging as well as blood and urine sampling as follows:
-Blood samples will be collected at 0 to 5 minutes, 10 to 15 minutes, 25 to 35 minutes, 60 ± 10 minutes, and then at 3 ± 1 hours, 6 ± 1 hours, 24 ± 3 hours, 48 ± 3 hours, 96 ± 24 hours and 168 ± 24 hours after IMP administration (168 ± 24 hours post injection measurements might be omitted for later participants of a DL if no relevant signals are found for Cycle 1 of the first 3 participants in each DL).
-Urine samples will be collected at 60 ± 10 minutes, 6 ± 1 hours, 24 ± 3 hours, 48 ± 3 hours and 96 ± 24 hours after IMP administration.
-Whole body planar gamma camera assessments will be performed at 25 to 35 minutes, 3 ± 1 hours, 6 ± 1 hours, 24 ± 3 hours, 48 ± 3 hours, 96 ± 24 for later participants of a DL if no relevant signals are found for Cycle 1 of the first 3 participants in each DL).
-Abdominal SPECT/CT assessments will be performed at 6 ± 1 hours, 24 ± 3 hours, and 48 ± 3 hours after IMP administration.
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Secondary outcome [14]
439690
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Phase 1 Exploratory - Comparison of presence of visceral (lung, liver, adrenals and central nervous system) metastases and its association with participants’ biochemical response, rPFS and overall survival (OS).
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Assessment method [14]
439690
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To establish PSMA expression at baseline, participants must undergo PSMA receptor imaging according to local guidelines and with a PET tracer (gallium [68Ga] PSMA or fluorine [18F] PSMA). Tomographic hybrid imaging (PET/CT), providing three-dimensional information should be performed to alleviate the identification of the lesions, pre-defined per PCWG3 (based on CT/MRI/Bone scan).
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Timepoint [14]
439690
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The presence of visceral metastases during screening will be recorded.
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Eligibility
Key inclusion criteria
1. Male participants greater than or equal to 18 years of age
2. Provided written informed consent to participate in the trial
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
4. Histologically, pathologically, and/or cytologically confirmed metastatic adenocarcinoma of the prostate without significant (i.e., > 10%) sarcomatoid or spindle or neuroendocrine or small cell differentiation components
5. Stage IV prostate cancer with at least one lesion that is measurable on baseline CT or MRI, or present on bone scan imaging, obtained within 30 days prior to trial enrolment as per PCWG3 criteria
6. At least one PSMA PET/CT positive lesion (i.e., higher than liver uptake) within 30 days prior to enrolment
7. Serum/plasma PSA level > 2 ng/mL within 30 days prior to enrolment and progressing (greater than or equal to 25% and greater than or equal to 2 ng/mL) over a previous reference value measured at least 1 week prior
8. Castrate level of serum/plasma testosterone (i.e., less than or equal to 50 ng/dL or less than or equal to 1.73 nmol/L) obtained either by bilateral orchiectomy or by ongoing treatment with a fixed dose of a luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist). Participants without prior surgical castration must have initiated a LHRH analogue treatment at least 14 days before enrolment, which should be maintained at the same dose during the trial until documented radiographic progression according to PCWG3 criteria
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
All participants will be excluded from participation in the trial if one or more of the following criteria are met:
1. Having received more than 2 previous doses of PSMA-targeted radiopharmaceutical therapy (RPT). Last targeted RPT dose should have been administered greater than or equal to 12 weeks prior to enrolment to be eligible
2. Last treatment with external beam radiotherapy, or with radioactive bone-seekers should have been administered greater than or equal to 12 weeks prior to enrolment
3. Having received more than 3 systemic lines of therapy overall (luteinizing hormone-releasing hormone (LHRH) analogues excluded), regardless of the castration sensitivity status
4. One or more of the following PSMA PET/CT negative lesion types:
a. greater than or equal to 1.0 cm soft tissue component in a bone metastatic lesion
b. greater than or equal to 2.5 cm lymph node metastatic lesion
c. greater than or equal to 1.0 cm solid organ metastatic lesion
5. Any systemic anti-cancer therapy within 30 days prior to trial enrolment (except Androgen receptor axis targeted therapy (ARAT) for which 7 days are sufficient and except LHRH analogues without time restriction)
6. Any investigational therapeutic agents within 30 days or 5 half-life periods, whichever is longer, prior to trial enrolment
7. Major surgery within 30 days prior to trial enrolment
8. Received a live attenuated vaccine within 30 days prior to trial enrolment
9. Known hypersensitivity to the components of the trial therapy or its analogues.
10. History of brain metastases or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required if there is no history of this
11. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression unless appropriately treated beforehand and clinically stable for greater than or equal to 30 days
12. Severe uncontrolled non-malignant disease (e.g., psychiatric, infectious, autoimmune, metabolic or dementia), that may interfere with the objectives of the trial or with the safety or compliance of the participant, as judged by the Investigator. Specific attention should be paid to the risk of bleeding that is not properly treated and controlled, such as epistaxis, oesophageal varices or gastrointestinal bleeding
13. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. However, participants with such a prior history of other malignancy that has been adequately treated and who have been disease free for at least 3 years are eligible, as are, with no time restriction, participants with adequately treated low-grade malignancies which have low risk of recurrence such as non-melanoma skin cancer or superficial bladder cancer
14. Renal, hepatic, cardiovascular, or haematological organ dysfunction, potentially interfering with the safety of the trial treatments, including the following:
a. Renal:
i. Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] 2021 formula [local laboratory])
ii. Urinary tract obstruction or hydronephrosis unless effective catheterisation is in place
b. Hepatic:
i. Total bilirubin > 2 × upper limit of normal (ULN) or > 3 × ULN for participants with Gilbert’s disease or liver metastases
ii. Albumin < 30 g/L
iii. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 × ULN, with the exception that participants with liver metastasis must have AST and/or ALT less than or equal to 5 × ULN
c. Haematologic:
i. Platelet count less than or equal to 100 × 109/L
ii. Absolute neutrophil count (ANC) < 1.5 × 109 cells/L
iii. Haemoglobin concentration < 6.2 mmol/L (< 10.0 g/dL; measured at least 30 days after a previous transfusion if any given to the participant)
d. Cardiovascular:
i. Congestive heart failure (New York Heart Association [NYHA] classification III and IV), unstable angina
ii. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 450 milliseconds
iii. History or current diagnosis of ECG abnormalities indicating significant risk of safety for trial participants
15. Any ongoing greater than or equal to Grade 2 toxicities related to prior therapies, with the exception of alopecia of any grade, stable treated electrolyte abnormalities on replacement and Grade 2 peripheral neuropathy from previous standard or investigational therapies (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)
16. Male participants with female partners of childbearing potential, unless:
a. willing to practice full and true sexual abstinence, or
b. are surgically/permanently sterile (bilateral tubal occlusion, hysterectomy, or vasectomy), or
c. are willing to practice highly effective contraception in combination with a barrier method of contraception (e.g., condom). Contraception methods that are considered highly effective are: oral or non-oral (injected or implanted) non-oestrogen progesterone-based hormonal method; oral, intravaginal, or transdermal combined oestrogen and progesterone-based hormonal methods; and/or intrauterine device, and/or intrauterine hormone-releasing system. Sexual abstinence or the contraception methods described above must be followed throughout the entire trial period and for at least 14 weeks (half-lives of actinium-225 is 9.92 days) after the last treatment cycle
17. Current unmanageable urinary incontinence preventing safe administration of the IMP, in the Investigator’s opinion
18. Not able to declare meaningful informed consent on his own (e.g., with legal guardian for mental disorders) or any other vulnerable population to that sense (e.g., persons institutionalised, incarcerated etc.)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The Phase I part of the trial will be performed using a BOIN12 design. The coprimary focus will be on efficacy and toxicity. This Phase I will not be formally comparative, with statistical analysis focusing on the proportion of participants at each DL, with each level being considered individually. As more participants get added to the dose, the information will be updated in a Bayesian framework.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/09/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Funding & Sponsors
Funding source category [1]
316863
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Commercial sector/Industry
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Name [1]
316863
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ITM Oncologics GmbH
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Address [1]
316863
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Country [1]
316863
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Germany
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Primary sponsor type
Commercial sector/Industry
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Name
ITM Oncologics GmbH
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Address
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Country
Germany
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Secondary sponsor category [1]
319101
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Other Collaborative groups
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Name [1]
319101
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GenesisCare Clinical CRO Pty Ltd
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Address [1]
319101
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Country [1]
319101
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315622
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Bellberry Human Research Ethics Committee G
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Ethics committee address [1]
315622
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123 Glen Osmond Road Eastwood South Australia 5063
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Ethics committee country [1]
315622
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Australia
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Date submitted for ethics approval [1]
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03/04/2024
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Approval date [1]
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24/05/2024
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Ethics approval number [1]
315622
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2024-04-420
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Summary
Brief summary
The aim of this study is to determine the Optimal Biological Dose, and Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of Actinium (225Ac) Ibu-DAB-PSMA for the Treatment of PSMA-positive Progressive Metastatic Castration Resistant Prostate Cancer Who is it for? You may be eligible for this study if you are a Male participant aged at least 18 years have a histologically, pathologically, and/or cytologically confirmed metastatic adenocarcinoma of the prostate without significant sarcomatoid or spindle or neuroendocrine or small cell differentiation components. Stage IV prostate cancer with at least one lesion that is measurable on baseline CT or MRI, or present on bone scan imaging, obtained within 30 days prior to trial enrolment. At least one PSMA PET/CT positive lesion (i.e., higher than liver uptake) within 30 days prior to enrolment. Study details Participants will receive different numbers of doses in cycles (two, three, or six), which will test 3 different dose levels/strengths of ITM-22. Participants will then be tested for optimal biological dose, tolerability and safety, preliminary efficacy signals of actinium, pharmacokinetics and biomarkers. It is hoped that findings from this study will demonstrate that actinium (225Ac) Ibu-DAB-PSMA is safe and well tolerated by patients with progressive mCRPC. The results in this study will determine the optimal biological dose for expansion of the trial in phase 2.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Gary Tincknell
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Address
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Illawarra Cancer Care Centre, New Dapto Rd, Wollongong, NSW 2500
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Country
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Australia
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Phone
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+61 2 4222 5200
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Fax
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Email
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Gary.Tincknell@health.nsw.gov.au
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Contact person for public queries
Name
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Joseph Su
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Address
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GenesisCare Clinical CRO Building 7, The Mill, 41-43 Bourke Road Alexandria NSW 2015
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Country
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Australia
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Phone
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+61 455 862 083
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Fax
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Email
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Joseph.Su@genesiscare.com
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Contact person for scientific queries
Name
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Frank Fliegert
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Address
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ITM Oncologics GmbH, Walther-von-Dyck-Strasse 4, 85748 Garching/Munich
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Country
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Germany
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Phone
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+49 89 329 8986 6000
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Fax
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Email
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info-oncologics@itm-radiopharma.com
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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