Recruiting
Phase 1

CDR404

Sponsor:

CDR-Life AG

Code:

NCT06402201

Conditions

Select Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CDR404

Study Details

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

Study ID

NCT06402201

Start date

May 24, 2024

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CDR404

Dose escalation

Interventions

CDR404

IV infusions

Primary outcome measure

  • Presence of dose limiting toxicities (DLTs) [ Time Frame: From first dose to DLT period (21 days) ]
  • Incidence and severity of (serious) adverse events ([S]AEs) [ Time Frame: From first dose to 90 days after the last dose ]
  • Anti-tumor response: Overall Response Rate (ORR) [ Time Frame: From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months ]

Central Contacts and Locations

Central contacts

Dimitrios Chondros Chief Medical Officer, CDR-Life

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

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Lauren Miro

lem183@med.miami.edu

+1-305-243-7590

Principal Investigator:

Coral Olazagasti, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Cancer Answer Line

+1-800-865-1125CancerAnswerLine@med.umich.edu

Principal Investigator:

Paul Swiecicki, MD

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

Contacts

Providence Cancer Institute

CanRsrchStudies@providence.org

+1-503-215-5763

Principal Investigator:

Rom Leidner, MD

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19106

Contacts

Research Team

+1-215-829-7089PAhemoncResearch@uphs.upenn.edu

Principal Investigator:

Mark Diamond, MD

More Information

Sponsor

CDR-Life AG

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CDR-Life AG on 2026-02-27.