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

NCT04553692 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2025-03-28

No results posted yet for this study

Summary

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

Interventions

DRUG

Aplitabart (IGM-8444)

DR5 Agonist Investigational Drug

DRUG

FOLFIRI

Chemotherapy Regimen

DRUG

Bevacizumab (and approved biosimilars)

Targeted Therapy

DRUG

Birinapant

SMAC-mimetic Investigational Drug

DRUG

Venetoclax

Targeted Therapy

DRUG

Gemcitabine

Chemotherapy

DRUG

Docetaxel

Chemotherapy

DRUG

Azacitidine

Chemotherapy

Sponsors & Collaborators

  • IGM Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Eric Humke, MD, PhD · IGM Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2025-01-20
Completion
2025-01-20
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • South Korea
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04553692 on ClinicalTrials.gov