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IMA401 TCER® in Recurrent and/or Refractory Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05359445
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : February 22, 2024
Bristol-Myers Squibb
Information provided by (Responsible Party):
Immatics Biotechnologies GmbH

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
Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer Biological: IMA401 (Phase Ia) Biological: IMA401 (Phase Ib) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2027

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)
Intravenous infusions in escalating dose levels

Biological: IMA401 (Phase Ib)
Treatment at recommended dose for extension (RDE)

Primary Outcome Measures :
  1. Number of patients with dose limiting toxicities [ Time Frame: 44 months ]

Secondary Outcome Measures :
  1. Number of patients with treatment-emergent adverse events (TEAEs) [ Time Frame: 68 months ]
  2. Number of patients with serious TEAEs [ Time Frame: 68 months ]
  3. Number of patients with treatment emergent adverse events of special interest (AESIs) [ Time Frame: 68 months ]
  4. Frequency of dose interruptions and reductions [ Time Frame: 68 months ]
  5. Duration of dose interruptions and reductions [ Time Frame: 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 [ Time Frame: 68 months ]
  7. Disease control rate (DCR) of CR, PR or stable disease (SD) lasting 6 or more weeks following the initiation of IMA401 [ Time Frame: 68 months ]
  8. Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST [ Time Frame: 68 months ]
  9. Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [ Time Frame: 68 months ]
  10. Overall survival (OS) [ Time Frame: 68 months ]
  11. Determination of PK parameter: maximal serum concentration (Cmax) [ Time Frame: 44 months ]
  12. Determination of PK parameter: time at Cmax (Tmax) [ Time Frame: 44 months ]
  13. Determination of PK parameter: minimal serum concentration (Cmin) [ Time Frame: 44 months ]
  14. Determination of PK parameter: area under the serum concentration-time curve (AUC) [ Time Frame: 44 months ]
  15. Determination of PK parameter: clearance (Cl) [ Time Frame: 44 months ]
  16. Determination of PK parameter: volume of distribution (Vss) [ Time Frame: 44 months ]
  17. Determination of PK parameter: half-life (t1/2) [ Time Frame: 44 months ]
  18. Determination of PK parameter: assessment of dose-proportionality [ Time Frame: 44 months ]
  19. Determination of PK parameter: steady-state attainment [ Time Frame: 44 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
  • Positive for HIV or with active hepatitis B or C infection.
  • Patients with any clinically relevant, active infection
  • Systemic corticosteroids (≥ 10 mg/day prednisone or equivalent) received 2 weeks prior to starting IMA401 therapy
  • Patients with active brain metastases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05359445

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Contact: Immatics Biotechnologies GmbH Please E-Mail

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Sponsors and Collaborators
Immatics Biotechnologies GmbH
Bristol-Myers Squibb
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Study Director: Immatics Biotechnologies GmbH Immatics Biotechnologies GmbH
Additional Information:
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Responsible Party: Immatics Biotechnologies GmbH Identifier: NCT05359445    
Other Study ID Numbers: IMA401-101
2023-506854-19-00 ( Other Identifier: Clinical Trials Information System )
First Posted: May 3, 2022    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes