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

NCT05702424 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IGM-7354-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

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.

Conditions

Solid Tumor

Keywords

Relapsed and/or Refractory; Metastatic Cancer; Advanced Tumors; Incurable

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Area Under the Curve (AUC) 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)

• Clearance (CL) 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)

• Volume of distribution (V) 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)

• Maximum Plasma Concentration (Cmax) 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)

• Objective Response Rate (ORR)

  Study duration of approximately 29 months

Study Arms (2)

IGM-7354 Single-Agent Dose Escalation

EXPERIMENTAL

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

Drug: IGM-7354

IGM-7354 Single-Agent Dose Expansion Serial Biopsy

EXPERIMENTAL

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

Drug: IGM-7354

Interventions

IGM-7354 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 Escalation; IGM-7354 Single-Agent Dose Expansion Serial Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IGM Biosciences, Inc.: lead

Study Sites (5)

Yale University

New Haven, Connecticut, 06520, United States

Location

Florida Cancer Specialists & Research Institute

Sarasota, Florida, 34232, United States

Location

Carolina Biooncology Institute

Huntersville, North Carolina, 28078, United States

Location

Oklahoma University

Norman, Oklahoma, 73019, United States

Location

START South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  IGM Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: January 27, 2023
• Study Start: January 10, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

US (5)