Back to resultsIMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
Primary Purpose
Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult
Status
Recruiting
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
IMA402 (Phase Ia)
IMA402 (Phase Ib)
IMA402 (Phase II)
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Cancer
Eligibility Criteria
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
Sites / Locations
- Universitaetsklinikum Heidelberg AöRRecruiting
- Universitaetsklinikum Ulm AöR
- Universitatsklinikum Erlangen AöR
- Universitaetsklinikum Regensburg
- Universitatsklinikum Wuerzburg AöRRecruiting
- Universitaetsklinikum Bonn AöR
- Marien Hospital Duesseldorf GmbHRecruiting
- Universitaetsklinikum Essen AöR
- Johannes Wesling Klinikum MindenRecruiting
- Universitaetsklinikum Magdeburg AöR
- Klinikum Chemnitz gGmbHRecruiting
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRRecruiting
- University Of Leipzig
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Dose escalation/de-escalation (Phase Ia)
Dose extension (Phase Ib)
Dose extension (Phase II)
Arm Description
Dose-Finding of IMA402 (Phase Ia)
IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)
Outcomes
Primary Outcome Measures
Phase I: Number of patients with dose limiting toxicities (DLTs)
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Phase I/II: Number of patients with serious TEAEs
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
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)
Secondary Outcome Measures
Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
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
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Phase I/II: Overall survival (OS)
Phase I/II: Determination of PK parameter: half-life (t1/2)
Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)
Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)
Phase I/II: Determination of PK parameter: area under the curve (AUC)
Full Information
NCT ID
NCT05958121
First Posted
July 14, 2023
Last Updated
October 16, 2023
Sponsor
Immatics Biotechnologies GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05958121
Brief Title
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2023 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immatics Biotechnologies GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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)
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Cancer, Recurrent Cancer, Solid Tumor, Adult, Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation/de-escalation (Phase Ia)
Arm Type
Experimental
Arm Description
Dose-Finding of IMA402 (Phase Ia)
Arm Title
Dose extension (Phase Ib)
Arm Type
Experimental
Arm Description
IMA402 monotherapy extension cohorts based on maximum tolerated dose (MTD) and/or recommended doses for extensions (RDEs) (Phase Ib)
Arm Title
Dose extension (Phase II)
Arm Type
Experimental
Arm Description
Selected ISEC investigated on MTD/RDEs based on a manageable/favorable safety profile and initial signs of anti-tumor activity (Phase II)
Intervention Type
Biological
Intervention Name(s)
IMA402 (Phase Ia)
Intervention Description
Intravenous infusions in escalating dose levels
Intervention Type
Biological
Intervention Name(s)
IMA402 (Phase Ib)
Intervention Description
Treatment at MTD and/or RDE (Phase Ib)
Intervention Type
Biological
Intervention Name(s)
IMA402 (Phase II)
Intervention Description
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)
Primary Outcome Measure Information:
Title
Phase I: Number of patients with dose limiting toxicities (DLTs)
Time Frame
24 months
Title
Phase I/II: Number of patients with treatment-emergent adverse events (TEAEs)
Time Frame
40 months
Title
Phase I/II: Number of patients with serious TEAEs
Time Frame
40 months
Title
Phase I/II: Frequency of dose interruptions and reductions, permanent discontinuations
Time Frame
40 months
Title
Phase I/II: Duration of dose interruptions and reductions, permanent discontinuations
Time Frame
40 months
Title
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)
Time Frame
40 months
Secondary Outcome Measure Information:
Title
Phase I: ORR based on BOR of CR and PR locally assessed using RECIST v1.1 and iRECIST
Time Frame
37 months
Title
Phase II: ORR based on BOR of CR and PR locally assessed using iRECIST
Time Frame
40 months
Title
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
Time Frame
40 months
Title
Phase I/II: Duration of response (DOR) of CR or PR based on RECIST v1.1 and iRECIST
Time Frame
40 months
Title
Phase I/II: Progression-free survival (PFS) based on RECIST v1.1 and iRECIST
Time Frame
40 months
Title
Phase I/II: Overall survival (OS)
Time Frame
40 months
Title
Phase I/II: Determination of PK parameter: half-life (t1/2)
Time Frame
40 months
Title
Phase I/II: Determination of PK parameter: minimal serum concentration (Cmin)
Time Frame
40 months
Title
Phase I/II: Determination of PK parameter: maximal serum concentration (Cmax)
Time Frame
40 months
Title
Phase I/II: Determination of PK parameter: area under the curve (AUC)
Time Frame
40 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Immatics Biotechnologies GmbH
Phone
Please E-Mail
Email
Ctgovinquiries@immatics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Immatics Biotechnologies GmbH
Organizational Affiliation
Immatics Biotechnologies GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Universitaetsklinikum Heidelberg AöR
City
Heidelberg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Ulm AöR
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Erlangen AöR
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitaetsklinikum Regensburg
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Universitatsklinikum Wuerzburg AöR
City
Wuerzburg
State/Province
Bavaria
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Bonn AöR
City
Bonn
State/Province
North Rhine-Westphalia
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Marien Hospital Duesseldorf GmbH
City
Duesseldorf
State/Province
North Rhine-Westphalia
ZIP/Postal Code
40479
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Essen AöR
City
Essen
State/Province
North Rhine-Westphalia
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Johannes Wesling Klinikum Minden
City
Minden
State/Province
North Rhine-Westphalia
ZIP/Postal Code
32429
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Magdeburg AöR
City
Magdeburg
State/Province
Saxony-Anhalt
ZIP/Postal Code
39120
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Klinikum Chemnitz gGmbH
City
Chemnitz
State/Province
Saxony
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Of Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Links:
URL
http://immatics.com/
Description
Corporate Website
Learn more about this trial
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
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