Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

Conditions

• Acute Myeloid Leukemia
• Chondrosarcoma
• Chronic Lymphocytic Leukemia
• Colorectal Cancer
• Non Hodgkin Lymphoma
• Sarcoma
• Small Lymphocytic Lymphoma
• Solid Tumor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Aplitabart (IGM-8444) — DRUG
  DR5 Agonist Investigational Drug
• FOLFIRI — DRUG
  Chemotherapy Regimen
• Bevacizumab (and approved biosimilars) — DRUG
  Targeted Therapy
• Birinapant — DRUG
  SMAC-mimetic Investigational Drug
• Venetoclax — DRUG
  Targeted Therapy
• Gemcitabine — DRUG
  Chemotherapy
• Docetaxel — DRUG
  Chemotherapy
• Azacitidine — DRUG
  Chemotherapy

Study Details

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.

Key Dates

Start date

Sep 23, 2020

Status verified

Mar 2025

Primary completion

Jan 20, 2025

Completion

Jan 20, 2025

Study Design

Enrollment

272 participants (actual)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Ph1a: Aplitabart Single Agent Alternate Dosing Escalation
  Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule.
• Experimental: Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion
  Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab.
• Experimental: Ph1a: Aplitabart + Birinapant Escalation and Expansion
  Aplitabart will be administered intravenously in combination with Birinapant which will also be administered intravenously.
• Experimental: Ph1a: Aplitabart + Venetoclax Escalation and Expansion
  Aplitabart will be administered intravenously in combination with Venetoclax.
• Experimental: Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion
  Aplitabart will be administered intravenously in combination with Docetaxel and Gemcitabine.
• Experimental: Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion
  Aplitabart will be administered intravenously in combination with Venetoclax and Azacitidine.
• Experimental: Ph1b: Aplitabart + FOLFIRI + Bevacizumab
  Aplitabart will be administered intravenously in combination with FOLFIRI + bevacizumab
• Experimental: Ph1b: FOLFIRI + Bevacizumab
  Standard of Care FOLFIRI + bevacizumab will be administered intravenously

Primary Outcome Measure

Ph1a: Adverse Events of aplitabart as single agent and with FOLFIRI ± bevacizumab, aplitibart with birinapant, aplitibart with venetoclax, aplitibart with venetoclax and azacitadine, and aplitibart with gemcitabine and docetaxel [ Time Frame: From Cycle 1 Day 1 through 28 days after the final dose of study drug ]

Locations (37)

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