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

Part of paid clinical trials in Miami, Florida.

Sponsor
CDR-Life AG
Study ID
NCT06402201
Phase
PHASE1
Status
Recruiting
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Conditions

  • Select Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CDR404 — BIOLOGICAL
    IV infusions

Study Details

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.

Key Dates

Start date
May 24, 2024
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CDR404
    Dose escalation

Primary Outcome Measure

Presence of dose limiting toxicities (DLTs) [ Time Frame: From first dose to DLT period (21 days) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
+1-305-243-7590
Gilberto de Lima Lopes, MD (SUB_INVESTIGATOR)
Coral Olazagasti, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Cancer Answer Line
[email protected]
+1-800-865-1125
Paul Swiecicki, MD (PRINCIPAL_INVESTIGATOR)
Providence Cancer InstitutePortlandOregon97213
Providence Cancer Institute
[email protected]
+1-503-215-5763
Rom Leidner, MD (PRINCIPAL_INVESTIGATOR)
Pennsylvania HospitalPhiladelphiaPennsylvania19106
Research Team
[email protected]
+1-215-829-7089
Mark Diamond, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami· Miami, FLUniversity of Michigan· Ann Arbor, MIProvidence Cancer Institute· Portland, ORPennsylvania Hospital· Philadelphia, PA

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