UPCC 07924 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

Investigational Treatment for Solid Tumors Expressing Specific Antigens

Enrolling By Invitation
18 years or above
All
Phase 1
42 participants needed
1 Location

Brief description of study

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.

Detailed description of study

The CDR404-001 Phase 1 study will enrol patients with locally advanced, unresectable or metastatic tumors expressing MAGE-A4, which include advanced solid tumors, and will be conducted in multiple phases:

  1. To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404
  2. To assess preliminary evidence of anti-tumor activity of CDR404
  3. To characterise the pharmacokinetics of CDR404
  4. To characterise the immunogenicity of CDR404
  5. To assess translational biomarkers

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Select Advanced Solid Tumors
  • Age: 18 years or above
  • Gender: All

Inclusion 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

Exclusion Criteria:

  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.

This study investigates the safety, tolerability, and anti-tumor activity of an investigational medication in adult patients with solid tumors that express MAGE-A4, a specific tumor-associated antigen. The study focuses on individuals with the HLA-A*02:01 tissue marker, which is necessary for participation.

Participants will undergo various study procedures to evaluate the maximum tolerated dose and pharmacologically effective dose range of the investigational medication. The study will also assess preliminary anti-tumor activity, pharmacokinetics, immunogenicity, and translational biomarkers.

  • Who can participate: Adults with advanced solid tumors that express MAGE-A4 and have the HLA-A*02:01 tissue marker may participate. Eligible participants must have an ECOG performance status of 0 or 1 and have relapsed from, be refractory to, or intolerant of standard therapy.
  • Study details: Participants will receive the investigational medication and be monitored for safety and effectiveness. The study will include assessments of the medication's effects on the body, including its pharmacokinetics and immunogenicity.
Updated on 27 Feb 2026. Study ID: 24-0680
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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