EUCTR2021-005610-33-NLActive, not recruitingPhase 1
iPREDICT Trial: A Phase IIB, Open Label, Study of 89Zr-Df-Crefmirlimab PET/CT in Subjects with Selected Advanced or Metastatic Malignancies including Melanoma, Merkel Cell, Renal Cell and Non-Small Cell LungCancers, Scheduled to Receive Standard-of-Care Immunotherapy (IOT) as a Single Agent or Combination, to Predict Response to Therapy - iPREDICT
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ImaginAb, Inc.
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 2-10.
- •1. Subjects must meet ONE of the criteria a, b or c below:
- •a. For enrollment into Cohort A: Subjects with histologically confirmed advanced or metastatic nonuveal/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 Immunotherapy (IOT) alone (not to include cytotoxic chemotherapy) as first line treatment as per the local label/prescribing information and standard of care at the physicians discretion.
- •b. 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 as per the local label/prescribing information
- •and standard of care at the physicians discretion.
- •c. For enrollment into Cohort C: Subjects with histologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 expression = 50% tumour cells (TC) or = 10% tumour-infiltrating immune cells (IC) without EGFR mutations or ALK genomic aberrations and who are candidates to receive Atezolizumab as a monotherapy for first line treatment.
- •Subjects must meet All of the criteria 2-10 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:
- •Radiation Washout Period:
- •=4 weeks (=2 weeks for palliative stereotactic radiation without abdominal).
- •Chemotherapy or Targeted Therapy Washout Period:
- •=3 weeks (=2 weeks of 5-fluorouracial-based agents, folinate agents, and/or weekly paclitaxel; =2 weeks (or 5 half-lives, whichever is longer) for tyrosine kinase inhibitors; =6 weeks for nitrosoureas or mitomycin C).
- •Surgery Washout Period:
- •Fully recovered and free of complications.
- •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 standard of care, 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 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 and up to 30 days after the last administration of the investigational product or up to the time period according to the local label/prescribing information for standard of care IOT including Atezolizumab whichever is longer.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
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.
Investigators
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