No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Immatics Biotechnologies GmbH · Industry
Who this trial is looking for
This trial is looking for adult patients with certain types of solid tumors that keep coming back or don’t respond to treatment. Participants will take a new treatment called IMA402 to see how safe it is and if it helps shrink tumors.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I have a confirmed advanced solid tumor
I have measurable disease according to RECIST criteria
I have a confirmed HLA status
My performance status is 0 or 1
My blood, liver, and kidney functions are normal
You may not be able to join if
I have other active cancers that need treatment
I am pregnant or breastfeeding
I have a history of severe allergies to IMA402 or its components
I have severe uncontrolled medical conditions
I have active brain metastases or a history of bleeding in brain metastases
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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)
Trial Locations
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Facility
City
State
Country
Status
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 accordin…
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
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