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Keep this study
Lead
IGM Biosciences, Inc.
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Evaluation of IGM-7354 in Adults With Relapsed and/or Refractory Cancer
