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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase I: Number of patients with dose limiting toxicities (DLTs)
Timeframe: 24 months
2
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Timeframe: 40 months
3
Phase I/II: Number of patients with serious TEAEs
Timeframe: 40 months
4
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
Timeframe: 40 months
5
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
Timeframe: 40 months
6
Phase II: Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)