Evaluation of IGM-7354 in Adults 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.

Key Inclusion Criteria:Age > 18 years at time of signing ICFECOG Performance Status of 0 or 1Histologic 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 participantParticipants with either measurable or evaluable diseaseAdequate organ functionAt 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 therapyParticipants must be willing to have pre-treatment and on-treatment tumor biopsies for biomarker evaluationKey Exclusion Criteria:Inability to comply with study and follow-up proceduresPrior IL-15, IL-2, synthetic IL-2, or IL-2v based therapyHistory of severe allergic or anaphylactic reactions to monoclonal antibody therapyPalliative radiation to bone metastases within 2 weeks prior to Day 1Major surgical procedure within 4 weeks prior to Day 1Untreated 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 immunodeficiencyCurrent 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