Cancer, Recurrent Cancer, Refractory Cancer, Solid Tumor, Adult
Conditions
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)
Detailed 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)
Interventions
DRUGIMA402
IV infusions
DRUGIMA402 and checkpoint inhibitor
IMA402 IV infusions and checkpoint inhibitor
DRUGIMA402 and chemotherapy
IMA402 IV infusions and chemotherapy
DRUGIMA402 and IMA401
IMA402 and IMA401 IV infusions
DRUGIMA402 and monoclonal antibody
IMA402 IV infusions and monoclonal antibody
DRUGIMA402 and chemotherapy +/- monoclonal antibody
IMA402 IV infusions and chemotherapy +/- monoclonal antibody
Sponsors
Immatics Biotechnologies GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Number of patients with dose limiting toxicities (DLTs) | 24 months |
| Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) | 40 months |
| Phase I/II: Number of patients with serious TEAEs | 40 months |
| Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations | 40 months |
| Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations | 40 months |
| 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) | 40 months |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST | 37 months |
| Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST | 40 months |
| 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 | 40 months |
| Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST | 40 months |
| Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST | 40 months |
| Phase I/II: Overall survival (OS) | 40 months |
| Phase I/II: Determination of PK parameter: half-life (t1/2) | 40 months |
| Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) | 40 months |
| Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) | 40 months |
| Phase I/II: Determination of PK parameter: area under the curve (AUC) | 40 months |
Countries
Germany, Netherlands
Contacts
CONTACTImmatics Biotechnologies GmbH
STUDY_DIRECTORImmatics Biotechnologies GmbH
Immatics Biotechnologies GmbH
Outcome results
None listed