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Recruiting NCT05958121

IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

Phase I / Phase II Interventional Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IMA402, IMA402 and checkpoint inhibitor, IMA402 and chemotherapy, IMA402 and IMA401.
Who it may be relevant to
Registry conditions: Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) Targeting PRAME, as Monotherapy or in Combination With a Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors

Overview

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

  • Drug IMA402
    IV infusions
  • Drug IMA402 and checkpoint inhibitor
    IMA402 IV infusions and checkpoint inhibitor
  • Drug IMA402 and chemotherapy
    IMA402 IV infusions and chemotherapy
  • Drug IMA402 and IMA401
    IMA402 and IMA401 IV infusions
  • Drug IMA402 and monoclonal antibody
    IMA402 IV infusions and monoclonal antibody
  • Drug IMA402 and chemotherapy +/- monoclonal antibody
    IMA402 IV infusions and chemotherapy +/- monoclonal antibody

Primary outcome measures

  • Phase I: Number of patients with dose limiting toxicities (DLTs) [Time frame: 24 months]
  • Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) [Time frame: 40 months]
  • Phase I/II: Number of patients with serious TEAEs [Time frame: 40 months]
  • Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations [Time frame: 40 months]
  • Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations [Time frame: 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) [Time frame: 40 months]
Secondary outcome measures (10)
  • Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST [Time frame: 37 months]
  • Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST [Time frame: 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 [Time frame: 40 months]
  • Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST [Time frame: 40 months]
  • Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [Time frame: 40 months]
  • Phase I/II: Overall survival (OS) [Time frame: 40 months]
  • Phase I/II: Determination of PK parameter: half-life (t1/2) [Time frame: 40 months]
  • Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) [Time frame: 40 months]
  • Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) [Time frame: 40 months]
  • Phase I/II: Determination of PK parameter: area under the curve (AUC) [Time frame: 40 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 25 centers
  • Universitaetsklinikum Heidelberg AöR — Heidelberg
  • Thoraxklinik Heidelberg gGmbH — Heidelberg
  • Universitaetsklinikum Mannheim GmbH — Mannheim
  • Universitaetsklinikum Tuebingen AöR — Tübingen
  • Universitaetsklinikum Ulm AöR — Ulm
  • Universitaetsklinikum Erlangen AöR — Erlangen
  • Klinikum Nürnberg — Nuremberg
  • Universitaetsklinikum Regensburg — Regensburg
  • … and 17 more centers
Netherlands · 4 centers
  • Antoni von Leeuwenhoek- Netherlands Cancer Institute — Amsterdam
  • Leiden Universitair Medisch Centrum — Leiden
  • Universitair Medisch Centrum Groningen — Groningen
  • Universitair Medisch Centrum Utrecht — Utrecht

Identifiers

NCT: NCT05958121 · IMA402-101 · 2022-503133-54-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗