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IMA401 TCER® in Recurrent and/or Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT05359445
Recruitment Status : Recruiting
First Posted : May 3, 2022
Last Update Posted : February 22, 2024
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Immatics Biotechnologies GmbH

Tracking Information
First Submitted Date  ICMJE April 11, 2022
First Posted Date  ICMJE May 3, 2022
Last Update Posted Date February 22, 2024
Actual Study Start Date  ICMJE May 19, 2022
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2022)
Number of patients with dose limiting toxicities [ Time Frame: 44 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2022)
  • Number of patients with treatment-emergent adverse events (TEAEs) [ Time Frame: 68 months ]
  • Number of patients with serious TEAEs [ Time Frame: 68 months ]
  • Number of patients with treatment emergent adverse events of special interest (AESIs) [ Time Frame: 68 months ]
  • Frequency of dose interruptions and reductions [ Time Frame: 68 months ]
  • Duration of dose interruptions and reductions [ Time Frame: 68 months ]
  • 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 ]
  • 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 ]
  • Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST [ Time Frame: 68 months ]
  • Progression-free survival (PFS) based on RECIST v1.1 and iRECIST [ Time Frame: 68 months ]
  • Overall survival (OS) [ Time Frame: 68 months ]
  • Determination of PK parameter: maximal serum concentration (Cmax) [ Time Frame: 44 months ]
  • Determination of PK parameter: time at Cmax (Tmax) [ Time Frame: 44 months ]
  • Determination of PK parameter: minimal serum concentration (Cmin) [ Time Frame: 44 months ]
  • Determination of PK parameter: area under the serum concentration-time curve (AUC) [ Time Frame: 44 months ]
  • Determination of PK parameter: clearance (Cl) [ Time Frame: 44 months ]
  • Determination of PK parameter: volume of distribution (Vss) [ Time Frame: 44 months ]
  • Determination of PK parameter: half-life (t1/2) [ Time Frame: 44 months ]
  • Determination of PK parameter: assessment of dose-proportionality [ Time Frame: 44 months ]
  • Determination of PK parameter: steady-state attainment [ Time Frame: 44 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 IMA401 TCER® in Recurrent and/or Refractory Solid Tumors
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
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: IMA401 (Phase Ia)
    Intravenous infusions in escalating dose levels
  • Biological: IMA401 (Phase Ib)
    Treatment at recommended dose for extension (RDE)
Study Arms  ICMJE 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)

Interventions:
  • Biological: IMA401 (Phase Ia)
  • Biological: IMA401 (Phase Ib)
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: April 28, 2022)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2027
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT05359445
Other Study ID Numbers  ICMJE IMA401-101
2023-506854-19-00 ( 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 Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Immatics Biotechnologies GmbH Immatics Biotechnologies GmbH
PRS Account Immatics Biotechnologies GmbH
Verification Date February 2024

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