IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmatics Biotechnologies GmbH
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
IMA402
DrugIV infusions
IMA402 and checkpoint inhibitor
DrugIMA402 IV infusions and checkpoint inhibitor
IMA402 and chemotherapy
DrugIMA402 IV infusions and chemotherapy
IMA402 and IMA401
DrugIMA402 and IMA401 IV infusions
IMA402 and monoclonal antibody
DrugIMA402 IV infusions and monoclonal antibody
IMA402 and chemotherapy +/- monoclonal antibody
DrugIMA402 IV infusions and chemotherapy +/- monoclonal antibody
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: Dose escalation/de-escalation (Phase Ia)Experimental treatment 2 interventions
Group B: Dose extension (Phase Ib)Experimental treatment 6 interventions
Group C: Dose extension (Phase II)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Phase I: Number of patients with dose limiting toxicities (DLTs)
Time frame
24 months2
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Time frame
40 months3
Phase I/II: Number of patients with serious TEAEs
Time frame
40 months4
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
Time frame
40 monthsSecondary outcomes
1
Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
Time frame
37 months2
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
Time frame
40 months3
Phase I/II: Disease control rate (DCR) of CR, PR or stable disease (SD) (lasting 6 or more weeks) following the initiation of IMA402 based on RECIST v1.1 and iRECIST
Time frame
40 months4
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Time frame
40 monthsSponsors and contacts
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Source ClinicalTrials.gov