First-in-Human Study to Assess CDR404 in Participants with Solid Tumors

• Research type

  Research Study

• Full title

  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

• IRAS ID

  1011580

• Contact name

  Clare Price

• Contact email

  clare.price@cdr-life.com

• Sponsor organisation

  CDR-Life AG

• Clinicaltrials.gov Identifier

  NCT06402201

• Research summary

  This is a Phase I dose escalation study of CDR404 in participants with HLA-A*02:01 and MAGE-A4 positive squamous non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial cancer, triple-negative breast cancer, synovial sarcoma, myxoid/round cell liposarcoma, endometrial cancer, and other solid tumours. The study, which is in modular format, aims to establish the safety, tolerability, optimal dose, and anti-tumour activity of CDR404 either alone or in combination.
  The safety and tolerability of CDR404 monotherapy is investigated in Module 1. This Module is divided into two parts: Part A, for dose escalation, and Part B, for evaluating clinical efficacy and further dose optimization in tumour specific cohorts, that will be included after establishing the pharmacologically effective dose range (PEDR) and maximum tolerated dose (MTD) from Part A.
  After establishing the PEDR, Part B will be implemented via a substantial protocol amendment.
  CDR404 will be administered through an intravenous infusion or a subcutaneous injection. The treatment phase will last up to 24 months. After the last dose of CDR404 there will be a follow-up visit approximately 30 days which includes further assessments, and a safety follow up visit approximately 90 days after the last dose of CDR404. The patient will then be contacted by trial staff every 3 months to check on their wellbeing and any new anti-tumour treatments started after the trial treatment discontinuation.
  This study will include about 42 participants, at approximately 20 sites in the US, European Union and the UK

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  25/LO/0317

• Date of REC Opinion

  3 Jun 2025

• REC opinion

  Further Information Favourable Opinion