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IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor

NCT05359445 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2026-04-30

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors.

Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed.

Primary objective:

* To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab

Secondary objectives:

* To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab
* To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab
* To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab

Conditions

  • Refractory Cancer
  • Recurrent Cancer
  • Solid Tumor, Adult
  • Cancer

Interventions

BIOLOGICAL

IMA401 (Phase Ia)

Intravenous infusions in escalating dose levels

BIOLOGICAL

Pembrolizumab (Phase Ia)

Intravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab

BIOLOGICAL

IMA 401 (Phase Ib)

Treatment at recommended dose for extension (RDE)

Sponsors & Collaborators

  • Immatics Biotechnologies GmbH

    lead INDUSTRY

Principal Investigators

  • Immatics Biotechnologies GmbH · Immatics Biotechnologies GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2026-03-18
Completion
2029-12-31

Countries

  • Germany

Study Locations

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Entities

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 NCT05359445 on ClinicalTrials.gov