Trials / Active Not Recruiting
Active Not RecruitingNCT05359445
IMA401 TCER® in Recurrent and/or Refractory Solid Tumors, Alone or in Combination With a Checkpoint Inhibitor
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®), as Monotherapy or in Combination With Checkpoint Inhibitor in Patients With Recurrent and/or Refractory Solid Tumors.
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 95 (estimated)
- Sponsor
- Immatics Biotechnologies GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to evaluate the safety, tolerability and initial anti-tumor activity of IMA401 as monotherapy or in combination with checkpoint inhibitor in patients with recurrent and/or refractory solid tumors. Patients' HLA status and expression of the MAGE-A4 and/or MAGE-A8 target in the tumor must be confirmed. Primary objective: * To determine the maximum tolerated dose and/or recommended dose for extension for IMA401 as monotherapy and in combination with pembrolizumab Secondary objectives: * To characterize the safety and tolerability of IMA401 as monotherapy and in combination with pembrolizumab * To evaluate initial anti-tumor activity of IMA401 as monotherapy and in combination with pembrolizumab * To describe the pharmacokinetics of IMA401 as monotherapy and in combination with pembrolizumab
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | IMA401 (Phase Ia) | Intravenous infusions in escalating dose levels |
| BIOLOGICAL | Pembrolizumab (Phase Ia) | Intravenous infusions in escalating dose levels for combination of IMA 401 and Pembrolizumab |
| BIOLOGICAL | IMA 401 (Phase Ib) | Treatment at recommended dose for extension (RDE) |
Timeline
- Start date
- 2022-05-19
- Primary completion
- 2026-03-06
- Completion
- 2029-12-01
- First posted
- 2022-05-03
- Last updated
- 2026-04-17
Locations
21 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT05359445. Inclusion in this directory is not an endorsement.