Phase I, 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

Study Identifier:
CDR404-001
CT.gov Identifier:
NCT06402201
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-508808-38-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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.

The trial has two components: Part A –aiming to identify the pharmacologically effective dose range; Part B – dose optimization. Part A involves dose escalation using a Bayesian Optimal Interval Phase I/II (BOIN12) model assisted 3+3 design and can additionally evaluate different intravenous (IV) or subcutaneous (SC) dosing regimens. Part B aims to identify the optimal biological dose(s) of IV/SC CDR404 associated with reproducible anti-tumor responses in selected tumor types.

To evaluating the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of CDR404 in HLA-A*02:01+ patients with MAGE-A4+ solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: CDR404
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  • Drug: Biological: CDR404
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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
    • Key eligibility criteria include 1) age ≥ 18 years 2) advanced or metastatic disease, which has exhausted all standard-of-care regimens; 3) Eastern cooperative Oncology Group (ECOG) score 0 or 1; 4) participant is germline HLA-A*02:01+; 5) tumor MAGE-A4+ as determined by immunohistochemistry at a central laboratory.
    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.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Emiliano Calvo
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor