NCT05958121 IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
| NCT ID | NCT05958121 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Immatics Biotechnologies GmbH |
| Condition | Refractory Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2023-08-09 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 400 participants in total. It began in 2023-08-09 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 doses and/or recommended doses for extensions for IMA402 as monotherapy and in combination with pembrolizumab (Phase Ia) * To characterize the safety and tolerability of IMA402 as monotherapy and in combination (Phase I/II) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) Secondary objectives: * To evaluate the initial anti-tumor activity of IMA402 as monotherapy and in combination (Phase I) * To evaluate anti-tumor activity of IMA402 as monotherapy and in combination (Phase II) * To describe the PK of IMA402 as monotherapy and in combination (Phase I/II)
Eligibility Criteria
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 indicated standard-of-care treatments per cohort * 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 * The patient is pregnant or is breastfeeding * History of hypersensitivity to components of IMA402 or rescue medications; hypersensitivity to or contraindication according to current SmPC for respective combination medicinal product * The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's or sponsor'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, history of bleeding into brain metastases, known brain metastases who are receiving therapeutic anticoagulation
Contact & Investigator
Immatics Biotechnologies GmbH
STUDY DIRECTOR
Immatics Biotechnologies GmbH
Frequently Asked Questions
Who can join the NCT05958121 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Refractory Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05958121 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05958121 currently recruiting?
Yes, NCT05958121 is actively recruiting participants. Contact the research team at Ctgovinquiries@immatics.com for enrollment information.
Where is the NCT05958121 trial being conducted?
This trial is being conducted at Heidelberg, Germany, Heidelberg, Germany, Mannheim, Germany, Tübingen, Germany and 11 additional locations.
Who is sponsoring the NCT05958121 clinical trial?
NCT05958121 is sponsored by Immatics Biotechnologies GmbH. The principal investigator is Immatics Biotechnologies GmbH at Immatics Biotechnologies GmbH. The trial plans to enroll 400 participants.
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