Zr-Df-IAB22M2C (CD8 PET Tracer) for PET/CT in Patients With Metastatic Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    84
  • sponsor
    ImaginAb, Inc.
Updated on 11 May 2021

Summary

Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of Zr-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 Zr-Df-IAB22M2C, assess and quantify any detectable changes in Zr-Df-IAB22M2C uptake from Baseline to post-Treatment, establish the relationship of Zr-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 Zr-Df-IAB22M2C uptake with clinical response by RECIST 1.1/iRECIST and evaluate the correlation of Zr-Df-IAB22M2C uptake with immune infiltrates and other molecular biomarkers (CD4, CD8, PD-1 and PD-L1) expression by IHC.

Description

Protocol IAB-CD8-201 is a Phase II, Open Label, Multi-Dose Study of Zr-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 Zr-Df-IAB22M2C, assess and quantify any detectable changes in Zr-Df-IAB22M2C uptake from Baseline to post-Treatment, establish the relationship of Zr-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 Zr-Df-IAB22M2C uptake with clinical response by RECIST (Response evaluation criteria in solid tumors) version 1.1/iRECIST and evaluate the correlation of Zr-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 Zr-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 Zr-Df-IAB22M2C (CD8 PET Tracer); PET/CT scans at 243 hours after each infusion of Zr-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 Zr-Df-IAB22M2C and within 2 weeks after 2nd infusion of Zr-Df-IAB22M2C and its associated PET/CT scan. Archival tumor biopsy tissues obtained within 2 months prior to 1st infusion of Zr-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 Zr-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 Zr-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.

Details
Condition POSITRON EMISSION TOMOGRAPHY, emission computed tomography, Metastatic Solid Tumors, pet scan, pet imaging, pet scans
Treatment ⁸⁹Zr-Df-IAB22M2C
Clinical Study IdentifierNCT03802123
SponsorImaginAb, Inc.
Last Modified on11 May 2021

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