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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05702424
• Other study ID #: IGM-7354-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 10, 2023
• Est. completion date: March 2026

Study information

• Verified date: November 2023
• Source: IGM Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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

Locations

Country	Name	City	State
United States	Carolina Biooncology Institute	Huntersville	North Carolina
United States	Yale University	New Haven	Connecticut
United States	Oklahoma University	Norman	Oklahoma
United States	START South Texas Accelerated Research Therapeutics	San Antonio	Texas
United States	Florida Cancer Specialists & Research Institute	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
IGM Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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)