Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06402201

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

Led by CDR-Life AG · Updated on 2026-02-27

42

Participants Needed

18

Research Sites

188 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent
  • Positive for HLA-A*02:01
  • Tumor positive for MAGE-A4
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Have selected advanced solid tumors
  • Relapsed, refractory, or intolerant to standard therapy
  • Measurable disease according to RECIST v1.1
  • Have adequate organ function
  • Agree to use highly effective contraception if applicable
Not Eligible

You will not qualify if you...

  • Symptomatic or untreated central nervous system metastasis
  • Insufficient washout from prior anticancer therapy
  • Significant ongoing toxicity from prior anticancer treatment
  • Recent surgery
  • Clinically significant heart disease
  • Active infection requiring systemic antibiotics
  • Risk of HIV/AIDS-related outcomes
  • Active hepatitis B or C infection
  • Ongoing systemic steroid or immunosuppressive treatment
  • Significant secondary cancer
  • History of chronic or recurrent active autoimmune disease needing treatment
  • Uncontrolled illness
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 18 locations

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

2

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

3

Providence Cancer Institute

Portland, Oregon, United States, 97213

Actively Recruiting

4

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19106

Actively Recruiting

5

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium, 2650

Actively Recruiting

6

Institut Jules Bordet

Brussels, Belgium, 1070

Actively Recruiting

7

Cliniques Universitaires Saint-Luc, UCL Ouvain

Brussels, Belgium, 1200

Actively Recruiting

8

Universitair Ziekenhuis Gent

Ghent, Belgium, 9000

Actively Recruiting

9

Rigshospitalet

Copenhagen, Denmark, DK-2100

Actively Recruiting

10

Istituto Clinico Humanitas

Milan, Italy, 20089

Actively Recruiting

11

Isituto Europeo di Oncologia (IEO)

Milan, Italy, 20141

Actively Recruiting

12

Hospital Universitari Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

13

Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)

Barcelona, Spain, 08908

Actively Recruiting

14

Hospital 12 de Octubre

Madrid, Spain, 28041

Actively Recruiting

15

START Madrid

Madrid, Spain, 28050

Actively Recruiting

16

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Actively Recruiting

17

Instituto de Investigacion Sanitaria (INCLIVA)

Valencia, Spain, 46026

Actively Recruiting

18

Royal Marsden Hospital

Sutton, London, United Kingdom, SM2 5PT

Actively Recruiting

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Research Team

D

Dimitrios Chondros Chief Medical Officer, CDR-Life

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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