Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
EXCLUSION CRITERIA
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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Solid Tumor,Colorectal Cancer,Non Hodgkin Lymphoma,Sarcoma,Chondrosarcoma,Small Lymphocytic Lymphoma,Chronic Lymphocytic Leukemia,Acute Myeloid Leukemia
Age
18+
Phase
PHASE1
Participants Needed
430
Est. Completion Date
Aug 31, 2027
Treatment Type
INTERVENTIONAL
Sponsor
IGM Biosciences, Inc.
ClinicalTrials.gov NCT Identifier
NCT04553692
Study Number
IGM-8444-001
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