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Trial record 1 of 1 for:    IMa402
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IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT05958121
Recruitment Status : Recruiting
First Posted : July 24, 2023
Last Update Posted : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Immatics Biotechnologies GmbH

Tracking Information
First Submitted Date  ICMJE July 14, 2023
First Posted Date  ICMJE July 24, 2023
Last Update Posted Date May 16, 2024
Actual Study Start Date  ICMJE August 9, 2023
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2023)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2023)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
Official Title  ICMJE A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific TCER® Targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
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 dose and/or recommended dose for extension for IMA402 (Phase I)
  • To characterize the safety and tolerability of IMA402 (Phase I/II)
  • To evaluate anti-tumor activity of IMA402 (Phase II)

Secondary objectives:

  • To evaluate the initial anti-tumor activity of IMA402 (Phase I)
  • To evaluate anti-tumor activity of IMA402 (Phase II)
  • To describe the PK of IMA402 (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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory Cancer
  • Recurrent Cancer
  • Solid Tumor, Adult
  • Cancer
Intervention  ICMJE
  • Biological: IMA402 (Phase Ia)
    Intravenous infusions in escalating dose levels
  • Biological: IMA402 (Phase Ib)
    Treatment at MTD and/or RDE (Phase Ib)
  • Biological: IMA402 (Phase II)
    Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)
Study Arms  ICMJE
  • Experimental: Dose escalation/de-escalation (Phase Ia)
    Dose-Finding of IMA402 (Phase Ia)
    Intervention: Biological: IMA402 (Phase Ia)
  • Experimental: Dose extension (Phase Ib)
    IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
    Intervention: Biological: IMA402 (Phase Ib)
  • Experimental: Dose extension (Phase II)
    Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)
    Intervention: Biological: IMA402 (Phase II)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2023)		 145
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2027
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 all available indicated standard-of-care treatments
  • 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 (ongoing adjuvant anti-hormonal treatment is allowed)
  • The patient is pregnant or is breastfeeding
  • History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available
  • The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator'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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Immatics Biotechnologies GmbH Please E-Mail Ctgovinquiries@immatics.com
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05958121
Other Study ID Numbers  ICMJE IMA402-101
2022-503133-54-00 ( Other Identifier: Clinical Trials Information System )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Current Responsible Party Immatics Biotechnologies GmbH
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Immatics Biotechnologies GmbH
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Immatics Biotechnologies GmbH Immatics Biotechnologies GmbH
PRS Account Immatics Biotechnologies GmbH
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP