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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05013099


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05013099
Ethics application status
Date submitted
30/07/2021
Date registered
19/08/2021

Titles & IDs
Public title
Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies
Scientific title
A Phase IIB, Open Label, Study of Zirconium Zr 89 Crefmirlimab Berdoxam PET/CT in Subjects With Advanced or Metastatic Malignancies, Scheduled to Receive Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy
Secondary ID [1] 0 0
IAB-CD8-203
Universal Trial Number (UTN)
Trial acronym
iPREDICT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Merkel Cell Carcinoma, Unspecified 0 0
Renal Cell Carcinoma 0 0
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - zirconium Zr 89 crefmirlimab berdoxam

Experimental: Subjects with melanoma, Merkel cell, renal cell, or NSCLC - Eligible subjects will receive up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First scan within 14 days prior to the onset of IOT, and a second scan 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.


Treatment: Other: zirconium Zr 89 crefmirlimab berdoxam
Up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
Timepoint [1] 0 0
Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.
Secondary outcome [1] 0 0
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI)
Timepoint [1] 0 0
Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.
Secondary outcome [2] 0 0
Incidence and severity of AEs
Timepoint [2] 0 0
Up to 48 weeks or end of treatment.
Secondary outcome [3] 0 0
Incidence and severity of infusion or injection reactions
Timepoint [3] 0 0
33 days post infusion
Secondary outcome [4] 0 0
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
Timepoint [4] 0 0
Up to 48 weeks or end of treatment
Secondary outcome [5] 0 0
12-lead ECG ventricular rate (bpm)
Timepoint [5] 0 0
baseline to 48 weeks or end of study
Secondary outcome [6] 0 0
12-lead ECG PR interval (msec)
Timepoint [6] 0 0
baseline to 48 weeks or end of study
Secondary outcome [7] 0 0
12-lead ECG QRS interval (msec)
Timepoint [7] 0 0
baseline to 48 weeks or end of study
Secondary outcome [8] 0 0
12-lead ECG QT interval (msec)
Timepoint [8] 0 0
baseline to 48 weeks or end of study
Secondary outcome [9] 0 0
12-lead ECG QTc interval (msec)
Timepoint [9] 0 0
baseline to 48 weeks or end of study
Secondary outcome [10] 0 0
12-lead ECG Overall Result
Timepoint [10] 0 0
baseline to 48 weeks or end of study
Secondary outcome [11] 0 0
Anti-drug antibody
Timepoint [11] 0 0
baseline to 48 weeks or end of study
Secondary outcome [12] 0 0
Change in blood AST levels (U/L) from baseline.
Timepoint [12] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [13] 0 0
Change in blood ALT levels (U/L) from baseline.
Timepoint [13] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [14] 0 0
Change in blood ALP levels (U/L) from baseline.
Timepoint [14] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [15] 0 0
Change in blood bilirubin levels (mg/dL) from baseline.
Timepoint [15] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [16] 0 0
Change in blood LDH levels (U/L) from baseline.
Timepoint [16] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [17] 0 0
Change in blood BUN levels (mg/dL) from baseline.
Timepoint [17] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [18] 0 0
Change in blood GGT levels (U/L) from baseline.
Timepoint [18] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [19] 0 0
Change in serum creatinine levels (mg/dL) from baseline.
Timepoint [19] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [20] 0 0
Change in blood uric acid levels (mg/dL) from baseline.
Timepoint [20] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [21] 0 0
Change in blood sodium levels (mmol/L) from baseline.
Timepoint [21] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [22] 0 0
Change in blood potassium levels (mmol/L) from baseline.
Timepoint [22] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [23] 0 0
Change in blood chloride levels (mmol/L) from baseline.
Timepoint [23] 0 0
Baseline through 48 weeks or end of treatment.
Secondary outcome [24] 0 0
Change in blood glucose levels (mg/dL) from baseline.
Timepoint [24] 0 0
Baseline through 48 weeks or end of treatment.

Eligibility
Key inclusion criteria
* Subjects will be eligible for enrollment in the study if they meet ONE criteria a, b or c in point 1 and ALL the criteria in points 2-9.

1. Subjects must meet ONE of the criteria a, b or c below:

1. For enrollment into Cohort A: Subjects with histologically confirmed advanced or metastatic non-uveal/non-mucosal melanoma or merkel cell carcinoma (MCPyV positive and negative) who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment.
2. For enrollment into Cohort B: Subjects with histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma or Renal Cell Carcinoma with sarcomatoid features (regardless of subtype) as defined on pathologic examination by a component of clear cell or sarcomatoid, who are not amenable to surgical cure and are candidates to receive single- or combined IOT alone or IOT in combination with VEGFR-directed or tyrosine kinase inhibitor (not to include cytotoxic chemotherapy) as first or second line treatment
3. For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer without non-smoker/driver mutations who are not amenable to surgical cure, and are candidates to receive single- or combined IOT alone (not to include cytotoxic chemotherapy) as first or second line treatment as per the label/prescribing information at the physicians discretion.

i. Patients with driver mutations that are expected to show significant benefit from first line checkpoint inhibiter treatment (such as KRAS G12C mutations) are eligible if all other I/E criteria are met

Subjects must meet All of the criteria 2-9 below:
2. At least 1 RECIST 1.1-measurable. non-irradiated, non-osseous (unless there is an associated measurable soft-tissue component) lesion documented on intravenous (IV) contrast-enhanced CT or MRI (per RECIST criteria 1.1) prior to first zirconium Zr 89 crefmirlimab berdoxam administration.
3. Has an adequate amount of time between their prior treatment/procedure and the 1st administration of zirconium Zr 89 crefmirlimab berdoxam.
4. Eastern Cooperative Oncology Group (ECOG) performance status =2 and anticipated survival of at least 6 months.
5. Meeting all clinical safety lab values per institution's SOC, or investigator's discretion, for subjects receiving cancer treatment.
6. Male or female age =18 years.
7. Ability to understand the purposes and risks of the trial and has signed an Institutional Review Board (IRB) approved informed consent form.
8. Willingness and ability to comply with all protocol required procedures.
9. For men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:

1. Bone-only disease without a measurable soft tissue component on conventional imaging (MRI, PET, CT).
2. Subjects with skin-only (cutaneous) lesions will be excluded from the tumor biopsy assessment.
3. Serious nonmalignant disease, additional active malignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
4. Subjects with splenic dysfunction or who are status post splenectomy. Post-splenectomy subjects who develop an accessory spleen with clinical and radiographic evidence of splenic function will be allowed with prior approval from the Sponsor.
5. Corticosteroid therapy is prohibited if used for the treatment of inflammatory or autoimmune conditions. Patients with adrenal insufficiency from prior surgery or immunotherapy toxicity may be on standard chronic replacement doses of hydrocortisone that also require sporadic use of stress doses of steroid .
6. Pregnant women or nursing mothers.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - Macquarie Park
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Olivia Newton-John Cancer Research Insititute - Heidelberg
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
- Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
United States of America
State/province [5] 0 0
Washington
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Netherlands
State/province [7] 0 0
Gelderland
Country [8] 0 0
Netherlands
State/province [8] 0 0
Leiden
Country [9] 0 0
Switzerland
State/province [9] 0 0
Lausanne
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImaginAb, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Margolin, MD
Address 0 0
Providence Saint John's Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kristin Schmiedehausen, MD
Address 0 0
Country 0 0
Phone 0 0
+1-650-833-8819
Fax 0 0
Email 0 0
kristins@imaginab.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05013099

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 35
Austin Health - Austin Hospital
Recruitment hospital [2] 46
Peter MacCallum Cancer Centre
Recruitment postcode(s) [1] 40
3084
Recruitment postcode(s) [2] 51
3000
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
ImaginAb, Inc.
Primary sponsor address
423 Hindry Ave. Suite D
Inglewood, CA 90301 USA
Primary sponsor country
United States of America
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 31
St Vincent's Hospital (Melbourne) Human Research
Address [1] 31
41 Victoria Parade, Fitzroy, VIC 3065
Country [1] 31
Australia
Date submitted for ethics approval [1] 31
30/07/2021
Approval date [1] 31
02/09/2021
Ethics approval number [1] 31
 
Public notes

Contacts
Principal investigator
Title 261 0
Prof
Name 261 0
Andrew Scott
Address 261 0
145 Studley Rd, Heidelberg VIC 3084
Country 261 0
Australia
Phone 261 0
0394965088
Fax 261 0
Email 261 0
andrew.scott@onjcri.org.au
Contact person for public queries
Title 262 0
Name 262 0
Katherine Young
Address 262 0
423 Hindry Ave. Suite D, Inglewood, CA 90301
Country 262 0
United States of America
Phone 262 0
+1 310 645 1211
Fax 262 0
Email 262 0
kyoung@imaginab.com
Contact person for scientific queries
Title 263 0
Prof
Name 263 0
Andrew Scott
Address 263 0
145 Studley Rd, Heidelberg VIC 3084
Country 263 0
Australia
Phone 263 0
0394965088
Fax 263 0
Email 263 0
andrew.scott@onjcri.org.au