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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial registered on ANZCTR
Registration number
ACTRN12626000946314
Ethics application status
Approved
Date submitted
24/06/2026
Date registered
30/07/2026
Date last updated
30/07/2026
Date data sharing statement initially provided
30/07/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Study to evaluate the safety, effects, and early effectiveness of IDB-1829 in patients with advanced prostate cancer
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Scientific title
A Phase 1 Open-Label, Multicenter, First-in-Human Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDB-1829 as Monotherapy in Participants with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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Additional trial identifiers [1]
317413
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Metastatic Castration-Resistant Prostate Cancer
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Condition category
Condition code
Cancer
338189
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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 the intervention or exposure
-Participants will receive IDB-1829 orally (by mouth) once daily (QD) in continuous 21-day treatment cycles at four escalating dose levels- DL 1 (1 mg), DL 2 (2 mg), DL 3 (4mg), DL 4 (7 mg).
-Treatment duration will continue until unacceptable toxicity, disease progression, or study discontinuation criteria are met (Participant withdrawal of consent, Disease progression (radiographic or clinical), Investigator judgment that continued treatment is not in the participant's best interest, Pregnancy (of a Women of Childbearing Potential (WOCBP) partner), Sponsor decision to terminate the study)
-Up to 18 participants will be enrolled in this part with 4 planned cohorts
- Study Duration (per participant): Screening up to 28 days; treatment until disease progression, unacceptable toxicity, or other discontinuation criterion; 30-day safety follow-up (SFU); long-term follow-up every 3 months until 2 years after the last participant ends treatment or end of study (EOS).
- The Adherence to the intervention will be supervised by the Principal Investigator/ Study staff/ Nurse.
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Intervention code [1]
334247
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Treatment: Drugs
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Description of the comparator or control
No Control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), and serious adverse events (SAEs), and changes from baseline in laboratory assessments, electrocardiograms (ECGs), vital signs, and physical examinations (composite primary outcome)
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Assessment method [1]
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1. Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) v6.0 2. Adverse Events (AEs/SAEs/DLTs): Collected through clinical evaluation, subject interviews (Subject interviews will be conducted by qualified study staff in a one-on-one, semi-structured face-to-face interview during scheduled study visits, taking approximately 5–10 minutes per participant.), and spontaneous reporting; coded using MedDRA and graded using CTCAE v6.0. 4. Laboratory assessments: Blood and urine samples analyzed using standard clinical laboratory analyzers (hematology, biochemistry, urinalysis). 5. ECGs: Measured using 12-lead ECG machines, interpreted centrally or by qualified personnel. 6. Vital signs: Measured using validated instruments (e.g., automated blood pressure monitor, thermometer, pulse rate monitors) 7. Physical examination: Conducted by qualified study clinicians using standard clinical examination procedures.
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Timepoint [1]
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From Screening (-28 days to 0 days) through Safety follow up visit (Day 30) which applies for all the above assessments.
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Secondary outcome [1]
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Pharmacokinetics (PK) profile of IDB-1829
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Assessment method [1]
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Plasma pharmacokinetics will be evaluated using serial plasma samples collected at predefined timepoints. Pharmacokinetic parameters, including: Cmax- Maximum observed plasma drug concentration (directly determined from the plasma concentration-time profiles). Tmax- Time to maximum observed plasma drug concentration, AUC0–T- area under the concentration-time curve from time zero to the last measurable concentration, AUC0–8- AUC from time zero extrapolated to infinity, AUCt- AUC over the dosing interval
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Timepoint [1]
462180
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2 hours (Pre-dose) and multiple post-dose samples at 0.5, 1, 2, 4, and 8 hours on Cycle 1 Day 1 and Cycle 1 Day 15
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Secondary outcome [2]
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Preliminary antitumor activity (composite secondary outcome)
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Assessment method [2]
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Tumor response assessed by imaging using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and Prostate Cancer Working Group 3 (PCWG3) criteria, alongside serum prostate-specific antigen (PSA) measurements. Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria will be used where applicable.
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Timepoint [2]
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Baseline (Screening: Day -28 to Day 1); Cycle 1 Day 1, Day 8 (±2 days), Day 15 (±2 days); Cycle 2 Day 1, Day 8 (±2 days), Day 15 (±2 days); Day 1 of subsequent cycles (±2 days); Weeks 12, 18, and 24 (for Disease Control Rate and Prostate-Specific Antigen response); and up to End of Treatment (EOT).
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Eligibility
Key inclusion criteria
1. Age 18 or older
2. Confirmed diagnosis of prostate cancer (adenocarcinoma) that has spread to other parts of the body (metastatic disease)
3. Cancer has stopped responding to hormone therapy (castration-resistant prostate cancer, or mCRPC)
4. Currently on hormone therapy (androgen deprivation therapy) or has had surgical removal of the testicles, with testosterone levels at or below 50 ng/dL
5. Cancer has gotten worse on or after the most recent treatment
6. Able to carry out normal daily activities with little or no physical limitation (ECOG performance status 0 or 1)
7. Has received at least one prior treatment for mCRPC, including at least one hormonal therapy such as enzalutamide or abiraterone
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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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Healthy volunteers
No
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Key exclusion criteria
1. Received chemotherapy, immunotherapy, targeted therapy, or another investigational cancer treatment within 21 days before starting study treatment (or within 6 weeks for prior radiopharmaceutical therapy such as lutetium-177 PSMA)
2. Received radiation therapy within 28 days before starting study treatment
3. Prostate cancer with small cell or neuroendocrine features on any prior or current biopsy
4. Stroke or mini-stroke (TIA) within the past 6 months
5. History of organ transplant
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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
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
31/07/2026
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Actual
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Date of last participant enrolment
Anticipated
30/07/2027
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
18
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Interdict Bio
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Address [1]
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Country [1]
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Interdict Bio
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Address
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Country
United States of America
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Secondary sponsor category [1]
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None
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Name [1]
324861
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Address [1]
324861
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Country [1]
324861
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Bellberry Human Research Ethics Committee A
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Ethics committee address [1]
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https://bellberry.com.au/
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Ethics committee country [1]
320522
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Australia
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Date submitted for ethics approval [1]
320522
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27/05/2026
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Approval date [1]
320522
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26/06/2026
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Ethics approval number [1]
320522
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Summary
Brief summary
This study is testing a new medicine called IDB-1829 for advanced prostate cancer that no longer responds to standard hormone treatments. Who is it for? You may be eligible for this study if you are an adult with prostate cancer, where the cancer has stopped responding to hormone therapy. Participants in this study must have also received at least one prior treatment for resistant prostate cancer. Study details All participants in this study will be asked to take a dose of the new medicine daily in 21 day cycles. The number of cycles will depend on how the participant is responding to the treatment. Participants will also be asked to provide blood samples throughout the treatment, and be followed up for review of safety and via scans to assess changes in the cancer. It is hoped that this research will help determine if the new medicine is a viable option for the treatment of hormone resistant prostate cancer.
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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 Craig Gedye
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Address
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Icon Cancer Centre, 520 South Road Tennyson Centre Kurralta Park Adelaide South Australia 5037
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Country
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Australia
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Phone
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+61 08 84740220
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Cassandra Choe-Juliak
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Address
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Interdict Bio P.O. Box 460369 San Francisco, CA 94114
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Country
150739
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United States of America
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Phone
150739
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+1 347 433 7515
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Fax
150739
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Email
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[email protected]
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Contact person for scientific queries
Name
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Cassandra Choe-Juliak
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Address
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Interdict Bio P.O. Box 460369 San Francisco, CA 94114
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Country
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United States of America
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Phone
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+1 347 433 7515
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Fax
150740
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Email
150740
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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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