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A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, as Monotherapy or in Combination with a Checkpoint Inhibitor in Patients with Recurrent and/or Refractory Solid Tumors

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-503133-54-00
Acronym
IMA402-101
Enrollment
195
Registered
2023-07-17
Start date
2023-08-09
Completion date
Unknown
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Brief summary

Number of patients with dose-limiting toxicities (Phase I), Number of patients with treatment-emergent adverse events (TEAEs) (Phase I/II), Number of patients with serious TEAEs (Phase I/II), Frequency and duration of dose interruptions and reductions, permanent discontinuations (Phase I/II), Objective response rate based on best overall response of complete response and partial response locally assessed using RECIST 1.1 (Phase II)

Interventions

DRUGTOCILIZUMAB
DRUGHUMAN SERUM ALBUMIN
DRUGIMA402
DRUGPEMBROLIZUMAB

Sponsors

Immatics Biotechnologies GmbH
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of patients with dose-limiting toxicities (Phase I), Number of patients with treatment-emergent adverse events (TEAEs) (Phase I/II), Number of patients with serious TEAEs (Phase I/II), Frequency and duration of dose interruptions and reductions, permanent discontinuations (Phase I/II), Objective response rate based on best overall response of complete response and partial response locally assessed using RECIST 1.1 (Phase II)—

Countries

Germany, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026