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

NCT06402201 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CDR404-001
• Study Type: interventional
• Target: 42
• Locations: 6 countries
• Sites: 18

Brief Summary

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

Outcome Measures

Primary Outcomes (3)

• Presence of dose limiting toxicities (DLTs)

  per Protocol

  From first dose to DLT period (21 days)

• Incidence and severity of (serious) adverse events ([S]AEs)

  AEs, SAEs

  From first dose to 90 days after the last dose

• Anti-tumor response: Overall Response Rate (ORR)

  per RECIST 1.1

  From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

Secondary Outcomes (14)

• Disease control rate (DCR)

  From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

• Duration of response (DOR)

  From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

• Progression-free Survival (PFS)

  From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

• Overall Survival (OS)

  From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

• Maximum serum concentration of CDR404 (Cmax)

  At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)

Study Arms (1)

CDR404

EXPERIMENTAL

Dose escalation

Biological: CDR404

Interventions

CDR404 BIOLOGICAL

IV infusions

CDR404

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• HLA-A\*02:01 positive
• MAGE-A4 positive tumor
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) \[ECOG PS\] 0 or 1
• Selected advanced solid tumors
• Relapsed from, refractory to, or intolerant of standard therapy
• Measurable disease per RECIST v1.1
• Adequate organ function
• If applicable, must agree to use highly effective contraception

You may not qualify if:

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

Sponsors & Collaborators

• CDR-Life AG: lead

Study Sites (18)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Providence Cancer Institute

Portland, Oregon, 97213, United States

RECRUITING

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

RECRUITING

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

RECRUITING

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc, UCL Ouvain

Brussels, 1200, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Rigshospitalet

Copenhagen, DK-2100, Denmark

RECRUITING

Istituto Clinico Humanitas

Milan, 20089, Italy

RECRUITING

Isituto Europeo di Oncologia (IEO)

Milan, 20141, Italy

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO)

Barcelona, 08908, Spain

RECRUITING

Hospital 12 de Octubre

Madrid, 28041, Spain

RECRUITING

START Madrid

Madrid, 28050, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Instituto de Investigacion Sanitaria (INCLIVA)

Valencia, 46026, Spain

RECRUITING

Royal Marsden Hospital

Sutton, London, SM2 5PT, United Kingdom

RECRUITING

Central Study Contacts

Dimitrios Chondros Chief Medical Officer, CDR-Life

CONTACT

+41 44 515 7025; CDR404-001_Study@CDR-Life.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: IV dose escalation

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 7, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IT (2); US (4); BE (4); ES (6); DK (1); GB (1)