- First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors — Recruiting • Phase I • Oncology • NCT06402201.
- What is being tested: CDR404, a novel bispecific T-cell engaging antibody that targets MAGE-A4 expressing solid tumors in HLA-A*02:01 positive patients, with evaluation of safety, tolerability, and efficacy as a first-in-human study.
- Patient eligibility overview: Participants must be HLA-A*02:01 positive with confirmed MAGE-A4 expressing solid tumors; this genetic restriction ensures patients have the appropriate human leukocyte antigen type for the therapy to function.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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.
- : 1. Provision of written informed consent 2. HLA-A*02:01 positive 3. MAGE-A4 positive tumor 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) [ECOG PS] 0 or 1 5. Selected advanced solid tumors 6. Relapsed from, refractory to, or intolerant of standard therapy 7. Measurable disease per RECIST v1.1 8. Adequate organ function 9. If applicable, must agree to use highly effective contraception
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.