Phase 1a/1b Study of IGM-8444 Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers

Open to people ages 18 years and up

• Age ≥ 18 years at time of signing ICF
• ECOG Performance Status of 0 or 1
• Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts.
• Adequate hepatic and renal function and adequate bone marrow reserve function.
• For combination cohorts, patients must be eligible to receive the chemotherapy or targeted agent.
• Ph1a only: No more than three prior therapeutic regimens.
• Ph1b only: Must be FOLFIRI naive subjects and must have received only 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting.

• Inability to comply with study and follow-up procedures.
• Prior DR5 agonist therapy.
• Concomitant use of agents well-known to cause liver toxicity.
• Concomitant use of anti-cancer agents
• 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 (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible.
• Prior use of any chemotherapeutic agent or small molecule inhibitors (SMI) within 2 weeks or 5 half-lives, prior to the first dose of study treatment
• Treatment with a monoclonal antibody, or any other anticancer agent (including biologic, experimental, or hormonal therapy) investigational or otherwise, that is not chemotherapy or a SMI, within 4 weeks or five half-lives prior to first dose of study treatment.
• Ph1b: Subjects who have previously received FOLFIRI treatment for advanced or metastatic disease