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

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.

Conditions

Select Advanced Solid Tumors

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Select Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Portland

Providence Cancer Institute, Portland, Oregon, United States, 97213

Philadelphia

Pennsylvania Hospital, Philadelphia, Pennsylvania, United States, 19106

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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
  • 1. Symptomatic or untreated central nervous system metastasis
  • 2. Inadequate washout from prior anticancer therapy
  • 3. Significant ongoing toxicity from prior anticancer treatment
  • 4. Recent surgery
  • 5. Clinically significant cardiac disease
  • 6. Active infection requiring systemic antibiotic treatment
  • 7. Human immunodeficiency virus (HIV) at risk of acquired immunodeficiency syndrome (AIDS)-related outcomes
  • 8. Active hepatitis B virus (HBV) or hepatitis C virus (HBC)
  • 9. Ongoing treatment with systemic steroids or other immunosuppressive therapies
  • 10. Significant secondary malignancy
  • 11. History of chronic or recurrent active autoimmune disease requiring treatment
  • 12. Uncontrolled intercurrent illness
  • 13. Pregnancy or lactation.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CDR-Life AG,

Study Record Dates

2027-12-31