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

Sponsor
Immatics Biotechnologies GmbH (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05958121
Collaborator
(none)
145
Enrollment
13
Locations
3
Arms
49
Anticipated Duration (Months)
11.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Biological: IMA402 (Phase Ia)
  • Biological: IMA402 (Phase Ib)
  • Biological: IMA402 (Phase II)
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
145 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2027
Anticipated Study Completion Date :
Sep 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose escalation/de-escalation (Phase Ia)

Dose-Finding of IMA402 (Phase Ia)

Biological: IMA402 (Phase Ia)
Intravenous infusions in escalating dose levels
Experimental: Dose extension (Phase Ib)

IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)

Biological: IMA402 (Phase Ib)
Treatment at MTD and/or RDE (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)

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)

Outcome Measures

Primary Outcome Measures

  1. Phase I: Number of patients with dose limiting toxicities (DLTs) [24 months]

  2. Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs) [40 months]

  3. Phase I/II: Number of patients with serious TEAEs [40 months]

  4. Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations [40 months]

  5. Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations [40 months]

  6. 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 Outcome Measures

  1. Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST [37 months]

  2. Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST [40 months]

  3. 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]

  4. Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST [40 months]

  5. Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [40 months]

  6. Phase I/II: Overall survival (OS) [40 months]

  7. Phase I/II: Determination of PK parameter: half-life (t1/2) [40 months]

  8. Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin) [40 months]

  9. Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax) [40 months]

  10. Phase I/II: Determination of PK parameter: area under the curve (AUC) [40 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitaetsklinikum Heidelberg AöR Heidelberg Baden-Wuerttemberg Germany 69120
2 Universitaetsklinikum Ulm AöR Ulm Baden-Wuerttemberg Germany 89081
3 Universitatsklinikum Erlangen AöR Erlangen Bavaria Germany 91054
4 Universitaetsklinikum Regensburg Regensburg Bavaria Germany 93053
5 Universitatsklinikum Wuerzburg AöR Wuerzburg Bavaria Germany 97080
6 Universitaetsklinikum Bonn AöR Bonn North Rhine-Westphalia Germany 53127
7 Marien Hospital Duesseldorf GmbH Duesseldorf North Rhine-Westphalia Germany 40479
8 Universitaetsklinikum Essen AöR Essen North Rhine-Westphalia Germany 45147
9 Johannes Wesling Klinikum Minden Minden North Rhine-Westphalia Germany 32429
10 Universitaetsklinikum Magdeburg AöR Magdeburg Saxony-Anhalt Germany 39120
11 Klinikum Chemnitz gGmbH Chemnitz Saxony Germany 09116
12 Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR Dresden Saxony Germany 01307
13 University Of Leipzig Leipzig Saxony Germany 04103

Sponsors and Collaborators

  • Immatics Biotechnologies GmbH

Investigators

  • Study Director: Immatics Biotechnologies GmbH, Immatics Biotechnologies GmbH

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Immatics Biotechnologies GmbH
ClinicalTrials.gov Identifier:
NCT05958121
Other Study ID Numbers:
  • IMA402-101
  • 2022-503133-54-00
First Posted:
Jul 24, 2023
Last Update Posted:
Jul 24, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Recurrence

Study Results

No Results Posted as of Jul 24, 2023