NCT06402201

First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

Phase 1, First-in-Human Study to Assess the Safety, Tolerability and Anti-tumor Activity of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: CDR-Life AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

CDR404 is a highly potent and specific T-cell engaging bispecific and bivalent antibody designed for the treatment of cancers positive for the tumor-associated antigen melanoma-associated antigen 4 (MAGE-A4). This is a first-in-human study designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of CDR404 in adult patients who have the appropriate germline human leukocyte antigen HLA-A\*02:01 tissue marker and whose cancer is positive for MAGE-A4.

Detailed description

The CDR404-001 Phase 1 study will enrol patients with locally advanced, unresectable or metastatic tumors expressing MAGE-A4, which include advanced solid tumors, and will be conducted in multiple phases: 1. To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404 2. To assess preliminary evidence of anti-tumor activity of CDR404 3. To characterise the pharmacokinetics of CDR404 4. To characterise the immunogenicity of CDR404 5. To assess translational biomarkers

Conditions

• Select Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	CDR404	IV infusions

Timeline

• Start date: 2024-05-24
• Primary completion: 2026-06-30
• Completion: 2027-12-31
• First posted: 2024-05-07
• Last updated: 2026-02-27

Locations

18 sites across 6 countries: United States, Belgium, Denmark, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study