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Testing IMA401 with or without pembrolizumab in patients with advanced solid tumors

A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-Tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), as Monotherapy or in Combination With Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors.

Phase 1 Interventional Immatics Biotechnologies GmbH · NCT05359445

This study is testing a new treatment called IMA401, alone or with pembrolizumab, to see how safe it is and if it can help people with advanced solid tumors.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment95 (estimated)
Ages18 Years and up
SexAll
SponsorImmatics Biotechnologies GmbH Industry-sponsored
Drugs / interventionspembrolizumab, prednisone
Locations21 sites (Freiburg, Baden-Wurttemberg and 20 other locations)
Trial IDNCT05359445 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to determine the maximum tolerated dose of IMA401, both as a standalone treatment and in combination with pembrolizumab, for patients with recurrent or refractory solid tumors. The study will assess the safety and tolerability of IMA401, evaluate its initial anti-tumor activity, and describe its pharmacokinetics. Patients will be monitored for their response to the treatment and any side effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic solid tumors, specifically those with confirmed HLA status and MAGEA4/8 expression.

Not a fit: Patients with early-stage cancer or those who have not yet received standard treatments may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have not responded to existing therapies.

How similar studies have performed: Previous studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures
* Patients ≥ 18 years old
* Patients must have pathologically confirmed and documented advanced and/or metastatic NSCLC or HNSCC, other solid tumor may be considered
* Confirmed HLA status and IMA401 tumor target MAGEA4/8 expression (IMADetect®)
* Life expectancy \> 2 months
* ECOG Performance Status of 0 to 1
* Measurable disease according to RECIST 1.1
* Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status
* Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments
* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy

Exclusion Criteria:

* Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
* History of hypersensitivity to components of IMA401, CPI treatment or rescue medications, contraindication for pembrolizumab
* Patients with prior allogeneic stem cell transplantation or organ transplantation
* Patients with autoimmune diseases needing disease-directed treatment
* Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results
* Positive for HIV or with active hepatitis B or C infection.
* Patients with active infection
* Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting trial treatment
* Patients with active brain metastases and leptomeningeal metastases

Where this trial is running

Freiburg, Baden-Wurttemberg and 20 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Refractory CancerRecurrent CancerSolid Tumor, AdultCancer
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.