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A Phase II, Open Label, Multi-Dose Study OF ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients With Advanced or Metastatic Melanoma, Non Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck Selected to Receive Standard-of-Care Immunotherapy As Single Agent or in Combination

Description

Brief Summary
Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients with Advanced or Metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck Selected to Receive Standard-of-Care Immunotherapy as Single Agent or in Combination. This study will evaluate the safety of repeat doses of ⁸⁹Zr-Df-IAB22M2C, assess and quantify any detectable changes in ⁸⁹Zr-Df-IAB22M2C uptake from Baseline to post-Treatment, establish the relationship of ⁸⁹Zr-Df-IAB22M2C uptake in tumors with CD8+ TIL density, biodistribution, evaluate the variance in participants' gene expression pre- and post-Treatment, evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with clinical response by RECIST 1.1/iRECIST and evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with immune infiltrates and other molecular biomarkers (CD4, CD8, PD-1 and PD-L1) expression by IHC.


Detailed Description
Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) for Positron Emission Tomography (PET/CT) in Patients with Advanced or Metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck Selected to Receive Standard-of-Care Immunotherapy as Single Agent or in Combination. This study will evaluate the safety of repeat doses of ⁸⁹Zr-Df-IAB22M2C, assess and quantify any detectable changes in ⁸⁹Zr-Df-IAB22M2C uptake from Baseline to post-Treatment, establish the relationship of ⁸⁹Zr-Df-IAB22M2C uptake in tumors with CD8+ TIL density, biodistribution, evaluate the variance in participants' gene expression pre- and post-Treatment, evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with clinical response by RECIST (Response evaluation criteria in solid tumors) version 1.1/iRECIST and evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with immune infiltrates and other molecular biomarkers (CD4, CD8, PD-1 and PD-L1) expression by immunohistochemistry (IHC). The investigational imaging agent to be administered in this study will be ⁸⁹Zr-Df-IAB22M2C with whole body PET/CT imaging acquired within 1 week prior to the onset of immunotherapy and 4-5 weeks after start of immunotherapy. Approximately 84 participants are planned to be enrolled in this clinical study. Participants should expect to have Conventional CT Chest, Abdomen and Pelvis (including Neck for SCCHN subjects) or MRI or whole body 18-FDG-PET scan will be performed within 45 days prior to 1st infusion of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer); PET/CT scans at 24±3 hours after each infusion of ⁸⁹Zr-Df-IAB22M2C; and fresh tumor biopsy (1 to 3 core biopsies) will be performed at Baseline (-28 to -7 days prior to 1st infusion of ⁸⁹Zr-Df-IAB22M2C and within 2 weeks after 2nd infusion of ⁸⁹Zr-Df-IAB22M2C and its associated PET/CT scan. Archival tumor biopsy tissues obtained within 2 months prior to 1st infusion of ⁸⁹Zr-Df-IAB22M2C (CD8 PET Tracer) may be submitted in place of Baseline fresh biopsy, with approval from the Sponsor. In addition, anti-drug antibody (ADA) blood samples will be collected at the following time points: at Baseline, prior to receiving the 2nd infusion of ⁸⁹Zr-Df-IAB22M2C, and at End-of-Study safety follow-up visit. At each study visit, participants will be questioned concerning any new medications or changes in current medications including over-the-counter and topical medications. The safety monitoring practices employed by this protocol are adequate to protect the participants' safety and should detect all Treatment Emergent Adverse Events (TEAEs). The safety follow-up (4-6 weeks after the last dose of ⁸⁹Zr-Df-IAB22M2C) and the extended follow-up (up to 18 months after start of cancer treatment) to collect Standard of Care (SOC) imaging only were also established. A participant who completes Visit 9 will be considered to have completed the study. All participants have the right to withdraw at their own request at any point during the study without prejudice. Although participants do not need to give a reason for requesting withdrawal from the trial, the Investigator should make a reasonable effort to ascertain the reason(s), while fully respecting the participant's rights. A Statistical Analysis Plan (SAP) will be developed and approved before the database is locked. The SAP will present the detailed statistical methodology to be used in analyzing the efficacy and tabulating the safety data from this trial. All inferential statistical analyses will be based on a two-sided test with a Type I error rate of 0.05. The primary analysis of the primary and secondary outcome measures will be conducted using the Per Protocol (PP) population. Analyses of safety outcomes will be conducted using the safety population. Adverse events will be coded using the most recent version of MedDRA. TEAEs will be summarized by treatment group and by stage in the study, System Organ Class, and preferred term. In addition, all the data from physical examination, 12 Lead Electrocardiogram (ECG) and vital signs will also be descriptively summarized. The final statistical analysis of data will be performed after all clinical monitoring has been completed, all data queries have been resolved, and all data have been verified (Quality Control checked) prior to formal database lock. The Sponsor will authorize the final database lock. For quality control and quality assurance purpose, the Sponsor's designated monitor will visit the center(s) during the study as well as maintain frequent telephone and written communication to maintain current personal knowledge of the progress of a study. The Investigator will permit the Sponsor to monitor the study as frequently as is deemed necessary and provide access to medical records to ensure that data are being recorded adequately, that data are verifiable and that protocol adherence is satisfactory. The Investigator will permit representatives of the Sponsor and/or designated Contract Research Organization (CRO) to inspect all Case Report Forms (CRFs) and corresponding study participant original medical records (source documents) at regular intervals throughout the study. Site inspections serve to verify strict adherence to the protocol and the accuracy of the data being entered on the CRFs, in accordance with federal regulations. A Monitoring Log will be maintained at each study site that the monitor will sign, date, and state the type of visit.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria: Participants will be eligible for enrollment in the study only if they meet ALL of the following criteria:
  • Patients with advanced or metastatic Melanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma or Squamous Cell Carcinoma of the Head and Neck with at least one non-radiated lesion, who are scheduled to begin standard of care immunotherapy.
  • • At least 1 non radiated measurable lesion documented on CT/, MRI (per RECIST criteria 1.1) or are FDG avid on FDG-PET within 45 days prior to first 89Zr-Df-IAB22M2C (CD8 PET Tracer) infusion.
  • At least 1 non-cutaneous lesion that is accessible, per investigator's assessment, and eligible for biopsy. If only a single RECIST measurable lesion is present, investigator to determine if the tumor biopsy could interfere with RECIST assessments of response.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Meeting all clinical safety lab values per institution's standard of care, or Investigator's discretion, for patients receiving cancer treatment.
  • Age ≥ 18 years.
  • Ability to understand the purposes and risks of the trial and has signed an IRB-approved informed consent form.
  • Willingness and ability to comply with all protocol required procedures.
  • 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. Exclusion Criteria: Subjects will NOT be eligible for enrollment in the study if they meet ANY of the following criteria:
  • Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
  • Patients with a single RECIST measurable lesion, biopsy of which, per investigator's assessment, is likely to interfere with RECIST assessments of response.
  • Patients who have any splenic disorders, or had splenectomy, that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives.
  • Pregnant women or nursing mothers.
  • Life expectancy < 6 months

Sites

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