Clinical trial NCT05702424: Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer
Official title: An Open-Label, Multicenter, Phase 1 Study of IGM-7354 in Adult Participants With Relapsed and/or Refractory Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Keywords: Relapsed and/or Refractory
Metastatic Cancer
Advanced Tumors
Incurable
Lead sponsor: IGM Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
timeFrame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Secondary outcomes:
measure: Area Under the Curve (AUC) of IGM-7354
timeFrame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
measure: Clearance (CL) of IGM-7354
timeFrame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
measure: Volume of distribution (V) of IGM-7354
timeFrame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
measure: Maximum Plasma Concentration (Cmax) of IGM-7354
timeFrame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
measure: Objective Response Rate (ORR)
timeFrame: Study duration of approximately 29 months
measure: Duration of Response (DoR)
timeFrame: Study duration of approximately 29 months
measure: Progression-Free Survival (PFS)
timeFrame: Study duration of approximately 29 months
measure: Anti-drug antibodies (ADAs) of IGM-7354
timeFrame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Sarasota
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Huntersville
country: United States
facility: Carolina Biooncology Institute
state: North Carolina
city: Norman
country: United States
facility: Oklahoma University
state: Oklahoma
city: San Antonio
country: United States
facility: START South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: IGM Biosciences
name: Clinical Trials
role: STUDY_DIRECTOR
References: