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IMA401 TCER® in Recurrent and/or Refractory Solid Tumors

Sponsor
Immatics Biotechnologies GmbH (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05359445
Collaborator
Bristol-Myers Squibb (Industry)
50
Enrollment
14
Locations
1
Arm
65.4
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary objective:
  • To determine the maximum tolerated dose and/or recommended dose for extension for IMA401
Secondary objectives:

  • To characterize the safety and tolerability of IMA401

  • To evaluate initial anti-tumor activity of IMA401

  • To describe the pharmacokinetics of IMA401

Condition or Disease Intervention/Treatment Phase
  • Biological: IMA401 (Phase Ia)
  • Biological: IMA401 (Phase Ib)
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase Ia/Ib First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA401, a Bispecific T Cell Engaging Receptor Molecule (TCER®), in Patients With Recurrent and/or Refractory Solid Tumors.
Actual Study Start Date :
May 19, 2022
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose-Finding Escalation/De-escalation (Phase Ia) and Extension Part (Phase Ib)

Dose-Finding Escalation/De-escalation of IMA401 (Phase Ia) IMA401 monotherapy extension cohort following the determination of the recommended dose for extension (RDE) (Phase Ib)

Biological: IMA401 (Phase Ia)
Weekly intravenous infusions in escalating dose levels

Biological: IMA401 (Phase Ib)
Treatment at recommended dose for extension (RDE) with weekly intravenous infusion

Outcome Measures

Primary Outcome Measures

  1. Number of patients with dose limiting toxicities [44 months]

Secondary Outcome Measures

  1. Number of patients with treatment-emergent adverse events (TEAEs) [68 months]

  2. Number of patients with serious TEAEs [68 months]

  3. Number of patients with treatment emergent adverse events of special interest (AESIs) [68 months]

  4. Frequency of dose interruptions and reductions [68 months]

  5. Duration of dose interruptions and reductions [68 months]

  6. Overall response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) locally assessed using RECIST v1.1 and iRECIST [68 months]

  7. Disease control rate (DCR) of CR, PR or stable disease (SD) lasting 6 or more weeks following the initiation of IMA401 [68 months]

  8. Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST [68 months]

  9. Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [68 months]

  10. Overall survival (OS) [68 months]

  11. Determination of PK parameter: maximal serum concentration (Cmax) [44 months]

  12. Determination of PK parameter: time at Cmax (Tmax) [44 months]

  13. Determination of PK parameter: minimal serum concentration (Cmin) [44 months]

  14. Determination of PK parameter: area under the serum concentration-time curve (AUC) [44 months]

  15. Determination of PK parameter: clearance (Cl) [44 months]

  16. Determination of PK parameter: volume of distribution (Vss) [44 months]

  17. Determination of PK parameter: half-life (t1/2) [44 months]

  18. Determination of PK parameter: assessment of dose-proportionality [44 months]

  19. Determination of PK parameter: steady-state attainment [44 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patients must have voluntarily signed a written ICF, be able to understand and comply with clinical trial procedures

  • Patients ≥ 18 years old

  • Patients must have pathologically confirmed and documented advanced and/or metastatic solid tumor

  • Confirmed HLA status and IMA401 tumor target MAGEA4/8 expression (IMADetect®)

  • Life expectancy > 2 months

  • ECOG Performance Status of 0 to 2

  • Measurable disease according to RECIST 1.1

  • Adequate baseline hematologic, renal and hepatic function; acceptable coagulation status

  • Patients must have recurrent and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatments

  • The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to treatment start. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities, in case if these toxicities are not anticipated to further improve (e.g., chronic peripheral neuropathy) and such toxicities are not anticipated to worsen with the IMA401 therapy

Exclusion Criteria:

  • Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)

  • History of hypersensitivity to components of IMA401 or rescue medications, if no alternative treatment option is available

  • Patients with prior allogeneic stem cell transplantation or organ transplantation

  • Patients with autoimmune diseases needing disease-directed treatment

  • Any serious or uncontrolled health condition, which, in the opinion of the Investigator, would place the subject at undue risk from the study, impair the ability of the subject to receive protocol specified therapy, or interfere with the interpretation of study results

  • Active infection by human immunodeficiency virus, hepatitis B or C

  • Patients with any clinically relevant, active viral infection

  • Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting IMA401 therapy

  • Patients with active brain metastases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitätklinikum Tübingen Comprehensive Cancer Center Tübingen Tübingen Baden-Wurttemberg Germany 72076
2 Heidelberg University Hospital (UKHD) Nationales Zentrum für Tumorkrankheiten Heidelberg Baden-Württemberg Germany 69120
3 Universitätsklinikum Ulm Zentrum für Innere Medizin Klinik für Innere Medizin III Clinical Trials Unit (CTU) Ulm Baden-Württemberg Germany 89081
4 Universitätsklinikum Erlangen Interdisciplinary Clinical Trial Unit with ECTU Erlangen Bavaria Germany 91054
5 Klinikum rechts der Isar der TU München Munich Bavaria Germany 81675
6 Universitätsklinikum Regensburg Regensburg Bavaria Germany 93053
7 Universitätsklinikum Würzburg Medizinische Klinik und Poliklinik II Interdisziplinäres Studienzentrum mit ECTU Würzburg Bavaria Germany 97078
8 Universitätsklinikum Bonn Bonn North Rhine-Westphalia Germany 53127
9 Marien Hospital Düsseldorf Düsseldorf North Rhine-Westphalia Germany 40479
10 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz North Rhine-Westphalia Germany 55131
11 Klinikum Chemnitz Klinik für Innere Medizin III Chemnitz Saxony Germany 09116
12 Universitätsklinikum C. - G. - Carus Universitäts KrebsCentrum Bereich: Early Clinical Trial Unit Dresden Saxony Germany 01307
13 Charité Benjamin Franklin Berlin Germany 12203
14 Universitäres Krebszentrum Leipzig (UCCL) Leipzig Germany 04103

Sponsors and Collaborators

  • Immatics Biotechnologies GmbH
  • Bristol-Myers Squibb

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:
NCT05359445
Other Study ID Numbers:
  • IMA401-101
  • 2021-004326-30
First Posted:
May 3, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
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 Aug 17, 2022