IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

Immatics

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Recurrent Cancer; Solid Tumor, Adult; Refractory Cancer; Cancer

Treatments: Biological: IMA402 (Phase Ib); Biological: IMA402 (Phase II); Biological: IMA402 (Phase Ia)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05958121

2022-503133-54-00 (Other Identifier)

IMA402-101

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors.

Primary objectives:

• To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I)
• To characterize the safety and tolerability of IMA402 (Phase I/II)
• To evaluate anti-tumor activity of IMA402 (Phase II)

Secondary objectives:

• To evaluate the initial anti-tumor activity of IMA402 (Phase I)
• To evaluate anti-tumor activity of IMA402 (Phase II)
• To describe the PK of IMA402 (Phase I/II)

Full description

The study will be conducted in two phases:

• Phase Ia: Dose escalation/de-escalation
• Phase Ib: Dose extension
• Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)

Enrollment: 145 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients ≥ 18 years old
• Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication
• Patients must have received or not be eligible for all available indicated standard-of-care treatments
• Measurable disease according to RECIST 1.1
• Confirmed HLA status
• ECOG Performance Status of 0 to 1
• Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status

Exclusion criteria

• Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
• The patient is pregnant or is breastfeeding
• History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available
• The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
• Patients with active brain metastases

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 3 patient groups

Dose escalation/de-escalation (Phase Ia)

Experimental group

Description:

Dose-Finding of IMA402 (Phase Ia)

Treatment:

Biological: IMA402 (Phase Ia)

Dose extension (Phase Ib)

Experimental group

Description:

IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)

Treatment:

Biological: IMA402 (Phase Ib)

Dose extension (Phase II)

Experimental group

Description:

Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)

Treatment:

Biological: IMA402 (Phase II)