RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2024-05-24
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06402201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of written informed consent
  2. 2. HLA-A\*02:01 positive
  3. 3. MAGE-A4 positive tumor
  4. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1
  5. 5. Selected advanced solid tumors
  6. 6. Relapsed from, refractory to, or intolerant of standard therapy
  7. 7. Measurable disease per RECIST v1.1
  8. 8. Adequate organ function
  9. 9. If applicable, must agree to use highly effective contraception
  1. 1. Symptomatic or untreated central nervous system metastasis
  2. 2. Inadequate washout from prior anticancer therapy
  3. 3. Significant ongoing toxicity from prior anticancer treatment
  4. 4. Recent surgery
  5. 5. Clinically significant cardiac disease
  6. 6. Active infection requiring systemic antibiotic treatment
  7. 7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes
  8. 8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
  9. 9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
  10. 10. Significant secondary malignancy
  11. 11. History of chronic or recurrent active autoimmune disease requiring treatment
  12. 12. Uncontrolled intercurrent illness
  13. 13. Pregnancy or lactation.

Contacts and Locations

Study Contact

Shet Biswas Chief Medical Officer, CDR-Life
CONTACT
+41 44 515 98 98
CDR404-001_Study@CDR-Life.com

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Providence Cancer Institute
Portland, Oregon, 97213
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19106
United States

Collaborators and Investigators

Sponsor: CDR-Life AG

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-24
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-05-24
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Select Advanced Solid Tumors