Trial Title:
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
NCT ID:
NCT05958121
Condition:
Refractory Cancer
Recurrent Cancer
Solid Tumor, Adult
Cancer
Conditions: Official terms:
Recurrence
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
IMA402 (Phase Ia)
Description:
Intravenous infusions in escalating dose levels
Arm group label:
Dose escalation/de-escalation (Phase Ia)
Intervention type:
Biological
Intervention name:
IMA402 (Phase Ib)
Description:
Treatment at MTD and/or RDE (Phase Ib)
Arm group label:
Dose extension (Phase Ib)
Intervention type:
Biological
Intervention name:
IMA402 (Phase II)
Description:
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of
anti-tumor activity of selected ISEC (Phase II)
Arm group label:
Dose extension (Phase II)
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)
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Universitaetsklinikum Heidelberg AöR
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Mannheim GmbH
Address:
City:
Mannheim
Zip:
68167
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Ulm AöR
Address:
City:
Ulm
Zip:
89081
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Erlangen AöR
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Nürnberg
Address:
City:
Nuremberg
Zip:
90419
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Regensburg
Address:
City:
Regensburg
Zip:
93053
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Wuerzburg AöR
Address:
City:
Wuerzburg
Zip:
97080
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Bonn AöR
Address:
City:
Bonn
Zip:
53127
Country:
Germany
Status:
Recruiting
Facility:
Name:
Marien Hospital Duesseldorf GmbH
Address:
City:
Duesseldorf
Zip:
40479
Country:
Germany
Status:
Recruiting
Facility:
Name:
KEM I Evang. Kliniken Essen-Mitte gGmbH
Address:
City:
Essen
Zip:
45136
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Essen AöR
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Recruiting
Facility:
Name:
Johannes Wesling Klinikum Minden
Address:
City:
Minden
Zip:
32429
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Magdeburg AöR
Address:
City:
Magdeburg
Zip:
39120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinikum Chemnitz gGmbH
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
University Of Leipzig
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Status:
Recruiting
Facility:
Name:
Leiden Universitair Medisch Centrum
Address:
City:
Leiden
Zip:
2333 ZA
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Universitair Medisch Centrum Utrecht
Address:
City:
Utrecht
Zip:
3584 CX
Country:
Netherlands
Status:
Recruiting
Start date:
August 9, 2023
Completion date:
September 2027
Lead sponsor:
Agency:
Immatics Biotechnologies GmbH
Agency class:
Industry
Source:
Immatics Biotechnologies GmbH
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05958121
http://immatics.com/
