Clinical trial · Interventional
Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due strategic corporate pivot to focus on auto-immune indications
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chondrosarcoma | Chondrosarcoma | ONTOLOGY_EXACT | 0.98 |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Small Lymphocytic Lymphoma | Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Solid Tumor | Solid Neoplasm |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aplitabart (IGM-8444) | Drug | — | UNRESOLVED |
| Azacitidine | Drug | Azacitidine | ALIAS |
| Bevacizumab (and approved biosimilars) | Drug | Bevacizumab | ALIAS |
| Birinapant | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Ph1a: Aplitabart Single Agent Alternate Dosing Escalation
- description
- Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule.
- interventionNames
- Drug: Aplitabart (IGM-8444)
- type
- EXPERIMENTAL
- label
- Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion
- description
- Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab.
- interventionNames
- Drug: Aplitabart (IGM-8444)
- Drug: FOLFIRI
- Drug: Bevacizumab (and approved biosimilars)
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available