IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors
NCT05958121 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 145
Last updated 2025-11-18
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)
Conditions
- Refractory Cancer
- Recurrent Cancer
- Solid Tumor, Adult
- Cancer
Interventions
- BIOLOGICAL
-
IMA402 (Phase Ia)
Intravenous infusions in escalating dose levels
- BIOLOGICAL
-
IMA402 (Phase Ib)
Treatment at MTD and/or RDE (Phase Ib)
- BIOLOGICAL
-
IMA402 (Phase II)
Treatment at MTD/RDE based on a manageable/favorable safety profile and initial signs of anti-tumor activity of selected ISEC (Phase II)
Sponsors & Collaborators
-
Immatics Biotechnologies GmbH
lead INDUSTRY
Principal Investigators
-
Immatics Biotechnologies GmbH · Immatics Biotechnologies GmbH
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-09
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
Countries
- Germany
- Netherlands
Study Locations
More Related Trials
-
A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
NCT02705482 ·Status: COMPLETED ·Phase: PHASE1
-
T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-A*01 Positive
NCT02153905 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
NCT03503968 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
NCT02960594 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of IMM-6-415 in RAS/RAF Mutant Solid Tumors
NCT06208124 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors
NCT00352131 ·Status: COMPLETED ·Phase: PHASE1
-
Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors
NCT05286801 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Phase 1 Study of IM-1021 in Participants With Advanced Cancer
NCT06823167 ·Status: RECRUITING ·Phase: PHASE1
-
Treatment of Relapsed and/or Chemotherapy Refractory Advanced Malignancies by CART-meso
NCT02580747 ·Status: UNKNOWN ·Phase: PHASE1
-
Ivonescimab (PD-1/VEGF Bispecific Antibody) Plus Radiofrequency Ablation for Multiple Advanced Tumors After PD-1 Therapy Failure
NCT07095803 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
DC/AML Fusion Cell Vaccine vs Observation in Patients Who Achieve a Chemotherapy-induced Remission
NCT03059485 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
A Study of IMC-A12 Every 2 Weeks in Patients With Tumors Who No Longer Respond to Treatment or No Treatment is Available
NCT00785941 ·Status: COMPLETED ·Phase: PHASE1
-
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
NCT02834013 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
NCT00107159 ·Status: COMPLETED ·Phase: PHASE2
-
IMM2902, a HER2/SIRPα Bispecific MAb-Trap Antibody-receptor Fusion Protein, in Patients with HER2-expressing Advanced Solid Tumors
NCT05076591 ·Status: SUSPENDED ·Phase: PHASE1
-
Study of IMC-P115C in Advanced PRAME-Positive Cancers
NCT07156136 ·Status: RECRUITING ·Phase: PHASE1
-
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
NCT03190941 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Gene Modified Immune Cells After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors
NCT04119024 ·Status: RECRUITING ·Phase: PHASE1
-
Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma
NCT03325101 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
BOXR1030 T Cells in Subjects With Advanced GPC3-Positive Solid Tumors
NCT05120271 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes
NCT01273181 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Atezolizumab and Bevacizumab in Treating Patients With Rare Solid Tumors
NCT03074513 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
ImmuniCell® in Patients With Advanced Cancers
NCT02459067 ·Status: TERMINATED ·Phase: PHASE2
-
A Phase 1 Study of INCMGA00012 in Patients With Advanced Solid Tumors
NCT03059823 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
NCT03970382 ·Status: SUSPENDED ·Phase: PHASE1