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

Study Identifier:
IGM-7354-001
CT.gov Identifier:
NCT05702424
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
  • Hematological Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: IGM-7354 Single-Agent Dose Escalation
    • Read More
  • Drug: Experimental: IGM-7354 Single-Agent Dose Expansion Serial Biopsy
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    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

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Hematological Cancer