An Open-label, Multicenter, Phase 1a/1b Study of Aplitibart (IGM-8444) as a Single Agent and in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers

IGM-8444-001

This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of aplitabart as a single agent and in combination in participants with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of aplitabart+FOLFIRI+bevacizumab.

2020-09-23

2026-06-01

2027-08-01

Recruiting

Early phase I

430

Key Inclusion Criteria: * 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, participants must be eligible to receive the chemotherapy or targeted agent. * Ph1a only: No more than three prior therapeutic regimens. * Ph1b only: Must be FOLFIRI naïve participants and must have received only 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting - OR - FOLFIRI naïve participants that only received adjuvant therapy who progressed within six months after completing adjuvant therapy, and are confirmed to have locally advanced/metastatic disease Key Exclusion Criteria: * 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). Participants 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: Participants who have previously received FOLFIRI treatment in the adjuvant, advanced, or metastatic disease setting

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Phase 1a is non-randomized; Ph1b is randomized'}}, 'enrollmentInfo': {'count': 430, 'type': 'ESTIMATED'}}

2024-04-16