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

An Open-Label, Multicenter, Phase 1 Study of IGM-7354 in Adult Participants With Relapsed and/or Refractory Cancer

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: IGM-7354

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).

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Florida
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists & Research Institute
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolina BioOncology Institute
  • Oklahoma
    • Norman, Oklahoma, United States, 73019
      • Oklahoma University
  • Texas
    • San Antonio, Texas, United States, 78229
      • START South Texas Accelerated Research Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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

Key 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IGM-7354 Single-Agent Dose Escalation; IGM-7354 will be administered intravenously as a single agent.	Drug: 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
Experimental: 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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD	Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0	At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) of IGM-7354	Area Under the Curve (AUC) of IGM-7354 as a single agent	At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Clearance (CL) of IGM-7354	Clearance (CL) of IGM-7354 as a single agent	At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Volume of distribution (V) of IGM-7354	Volume of distribution (V) of IGM-7354 as a single agent	At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Maximum Plasma Concentration (Cmax) of IGM-7354	Maximum Plasma Concentration (Cmax) of IGM-7354 as a single agent	At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Objective Response Rate (ORR)	The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigators	Study duration of approximately 29 months
Duration of Response (DoR)	For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented CR or PR to the first documented disease progression or death, whichever occurs first.	Study duration of approximately 29 months
Progression-Free Survival (PFS)	PFS is defined as the time from first dose to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.	Study duration of approximately 29 months
Anti-drug antibodies (ADAs) of IGM-7354	Immunogenicity of IGM-7354	At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: IGM Biosciences, Inc.
• Investigators: Study Director: Clinical Trials, IGM Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Metastatic Cancer; Relapsed and/or Refractory; Advanced Tumors; Incurable
• Other Study ID Numbers: IGM-7354-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No