Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer

NCT ID: NCT05702424

Last Updated: 2024-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-05-31

Brief Summary

This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Study participation will consist of a 28-day screening period, a treatment period, and a safety follow-up period 90-days after the last dose.

Detailed Description

Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354.

IGM-7354 will be administered intravenously (IV).

Conditions

Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IGM-7354 Single-Agent Dose Escalation

IGM-7354 will be administered intravenously as a single agent.

Group Type: EXPERIMENTAL

IGM-7354

Intervention Type: DRUG

IGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects

IGM-7354 Single-Agent Dose Expansion Serial Biopsy

IGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies.

Group Type: EXPERIMENTAL

IGM-7354

Intervention Type: DRUG

IGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects

Interventions

IGM-7354

IGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age > 18 years at time of signing ICF
• ECOG Performance Status of 0 or 1
• Histologic or cytologic documentation of incurable, locally advanced or metastatic solid tumors for which standard therapies are not available, are no longer effective, are not tolerated, or have been declined by the participant
• Participants with either measurable or evaluable disease
• Adequate organ function
• At least 2 weeks prior to Day 1 or 5 half-lives, whichever is shorter, must have elapsed from the use of anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy
• Participants must be willing to have pre-treatment and on-treatment tumor biopsies for biomarker evaluation

Exclusion Criteria

• Inability to comply with study and follow-up procedures
• Prior IL-15, IL-2, synthetic IL-2, or IL-2v based therapy
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
• Palliative radiation to bone metastases within 2 weeks prior to Day 1
• Major surgical procedure within 4 weeks prior to Day 1
• Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible.
• Active autoimmune disease that has required systemic treatment in the past 2 years.
• Diagnosis of immunodeficiency
• Current Grade >1 toxicity from prior therapy. Participants with current Grade 2 chronic toxicities that are well-controlled by medications may be enrolled after discussion with medical monitor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IGM Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

IGM Biosciences

Locations

Yale University

New Haven, Connecticut, United States

Florida Cancer Specialists & Research Institute

Sarasota, Florida, United States

Carolina Biooncology Institute

Huntersville, North Carolina, United States

Oklahoma University

Norman, Oklahoma, United States

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Countries

United States

Other Identifiers

IGM-7354-001

Identifier Type: -

Identifier Source: org_study_id