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

NCT05958121
clinicaltrials.gov
Phase
Phase 1/Phase 2
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Recruitment status
Recruiting
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Participants
400
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Lead sponsor
Immatics Biotechnologies GmbH
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Start date
2023-08-09
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Number of sites
29
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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)
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Short title
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2027-09-01
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First posted
2023-07-24
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Registry last updated
2026-07-01
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Primary completion date
2027-09-01
clinicaltrials.gov
Start date
2023-08-09
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Participants
400
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Participant count basis
Estimated
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Planned participants
400
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Protocol amendments
1
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Number of sites
29
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Immatics Biotechnologies GmbH
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05958121
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05958121
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Phase I: Number of patients with dose limiting toxicities (DLTs)

    Timeframe: 24 months

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

    Timeframe: 40 months

  3. Phase I/II: Number of patients with serious TEAEs

    Timeframe: 40 months

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

    Timeframe: 40 months

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

    Timeframe: 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)

    Timeframe: 40 months

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

    Timeframe: 37 months

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

    Timeframe: 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

    Timeframe: 40 months

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

    Timeframe: 40 months

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

    Timeframe: 40 months

  6. Phase I/II: Overall survival (OS)

    Timeframe: 40 months

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

    Timeframe: 40 months

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

    Timeframe: 40 months

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

    Timeframe: 40 months

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

    Timeframe: 40 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyRecruiting
  • Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyNot yet recruiting
  • Universitaetsklinikum Mannheim GmbHMannheim, GermanyRecruiting
  • Universitaetsklinikum Tuebingen AöRTübingen, GermanyNot yet recruiting
  • Universitaetsklinikum Ulm AöRUlm, GermanyRecruiting
  • Universitaetsklinikum Erlangen AöRErlangen, GermanyRecruiting
  • Klinikum NürnbergNuremberg, GermanyRecruiting
  • Universitaetsklinikum RegensburgRegensburg, GermanyRecruiting
  • Universitaetsklinikum Wuerzburg AöRWürzburg, GermanyRecruiting
  • Goethe University FrankfurtFrankfurt am Main, GermanyRecruiting
  • Justus-Liebig-Universitaet GiessenGiessen, GermanyRecruiting
  • Philipps-Universitaet MarburgMarburg, GermanyRecruiting
  • Sana Klinikum Offenbach GmbHOffenbach, GermanyNot yet recruiting
  • Elbe Kliniken Stade- Buxtehude Elbe Klinikum Buxtehude gGmbHBuxtehude, GermanyRecruiting
  • Universitaetsmedizin GoettingenGöttingen, GermanyNot yet recruiting
  • Universitaetsklinikum Bonn AöRBonn, GermanyRecruiting
  • Marien Hospital Duesseldorf GmbHDüsseldorf, GermanyRecruiting
  • KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyRecruiting
  • Universitaetsklinikum Essen AöREssen, GermanyRecruiting
  • Johannes Wesling Klinikum MindenMinden, GermanyRecruiting
  • Universitaet MuensterMünster, GermanyNot yet recruiting
  • Klinikum Chemnitz gGmbHChemnitz, GermanyRecruiting
  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyRecruiting
  • University Of LeipzigLeipzig, GermanyRecruiting
  • Universitaetsklinikum Magdeburg AöRMagdeburg, GermanyRecruiting

And 4 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-503133-54-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)