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OncoMatch/Clinical Trials/NCT05359445

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

Is NCT05359445 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including IMA401 (Phase Ia) and Pembrolizumab (Phase Ia) for refractory cancer.

Phase 1RecruitingImmatics Biotechnologies GmbHNCT05359445Data as of May 2026

Treatment: IMA401 (Phase Ia) · Pembrolizumab (Phase Ia) · IMA 401 (Phase Ib)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

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Biomarker criteria

Required: MAGEA4 expression

Required: MAGEA8 expression

Performance status

ECOG 0–1(Restricted strenuous activity)

Lab requirements

Blood counts

adequate baseline hematologic function

Kidney function

adequate baseline renal function

Liver function

adequate baseline hepatic function

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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