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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05013099
Ethics application status
Date submitted
1/08/2021
Date registered
18/08/2021
Date last updated
18/08/2021

Titles & IDs
Public title
Study of 89Zr-Df-crefmirlimab PET/CT in Subjects With Advanced or Metastatic Malignancies
Scientific title
A Phase IIB, Open Label, Study of 89Zr-Df-Crefmirlimab 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
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
Other interventions - 89Zr-Df-Crefmirlimab

Experimental: Subjects with melanoma, Merkel cell, renal cell, or NSCLC - Eligible subjects will receive up to three 89Zr-Df-crefmirlimab 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 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 89Zr-Df-crefmirlimab infusion 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 89Zr-Df-crefmirlimab PET scan at the principal investigator's (PI's) discretion.


Other interventions: 89Zr-Df-Crefmirlimab
Up to three 89Zr-Df-crefmirlimab 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 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 89Zr-Df-crefmirlimab infusion 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 89Zr-Df-crefmirlimab PET scan at the principal investigator's (PI's) discretion.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the performance of 89Zr Df crefmirlimab positron emission tomography/computed tomography (PET/CT) for predicting patient response to immunotherapy. - Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
Timepoint [1] 0 0
Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.
Secondary outcome [1] 0 0
Evaluate the performance of 89Zr Df crefmirlimab PET/CT for predicting lesion response to immunotherapy. - 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) following onset of immuno-oncology treatment.
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
To assess safety of the repeat 89Zr Df crefmirlimab infusions. - Incidence and severity of AEs, infusion reactions, labs, and ECGs. Number of subjects withdrawn due AEs. Appearance of anti-drug antibodies.
Timepoint [2] 0 0
Up to 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 line treatment.

2. For enrollment into Cohort B: Subjects with histologically confirmed
advanced or metastatic nonpapillary Renal Cell Carcinoma who are not
amenable to surgical cure and are candidates to receive single- or combined
IOT alone or IOT in combination with 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-smokers/driver
mutations who are not amenable to surgical cure and are candidates to
receive Atezolizumab as a monotherapy for first line treatment.

Subjects must meet All of the criteria 2-9 below:

2. At least 1 RECIST 1.1-measurable. non-irradiated, non-cutaneous, 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 89Zr-Df-crefmirlimab infusion.

3. Has an adequate washout period before the date of consent as defined by:

4. Eastern Cooperative Oncology Group (ECOG) performance status ≤2 and anticipated
survival of at least 6 months.

5. Subject must be IOT naïve.

6. Meeting all clinical safety lab values per institution's SOC, or investigator's
discretion, for subjects receiving cancer treatment.

7. Male or female age ≥18 years.

8. Ability to understand the purposes and risks of the trial and has signed an
Institutional Review Board (IRB) approved informed consent form.

9. Willingness and ability to comply with all protocol required procedures.

10. 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
Gender
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 on conventional imaging (MRI, PET, CT) or skin- only lesions.

2. Serious nonmalignant disease or conditions that in the opinion of the
investigator and/or ImaginAb could compromise protocol objectives.

3. Subjects with splenic dysfunction or who are status post splenectomy will be
discussed on a case-by-case basis due to the importance of the spleen in CD8
imaging as a reference tissue.

4. Pregnant women or nursing mothers.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
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
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImaginAb, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
City of Hope Medical Center
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate whether 89Zr-Df-crefmirlimab PET can predict the
response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or
non-small cell lung cancer tumors to immuno-oncology therapy.
Trial website
https://clinicaltrials.gov/show/NCT05013099
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katherine Young
Address 0 0
Country 0 0
Phone 0 0
+1-310-645-1211
Fax 0 0
Email 0 0
kyoung@imaginab.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05013099