Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06402201 | RECRUITING | Select Advanced Solid Tumors

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

CDR-Life AG

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.

Condition or disease

Select Advanced Solid Tumors

Intervention/treatment

CDR404

Phase

PHASE1

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 42 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2024-05-24
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2027-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
First in Human Study of CDR404 in HLA-A*02:01 Participants With MAGE-A4 Expressing Solid Tumors

Location Details

NCT06402201

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Florida

University of Miami

Miami, Florida, United States, 33136

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48109

RECRUITING

United States, Oregon

Providence Cancer Institute

Portland, Oregon, United States, 97213

RECRUITING

United States, Pennsylvania

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19106

RECRUITING

Belgium,

University Hospital Antwerp

Antwerp, Belgium, 2650

RECRUITING

Belgium,

Institute Jules Table

Brussels, Belgium, 1070

RECRUITING

Belgium,

Saint-Luc university clinics, UCL ouvain

Brussels, Belgium, 1200

RECRUITING

Belgium,

University Hospital Ghent

Gent, Belgium, 9000

RECRUITING

Denmark,

Rigshospitalet

Copenhagen, Denmark, DK-2100

RECRUITING

Italy,

Humanitas Clinical Institute

Milan, Italy, 20089

RECRUITING

Italy,

European Institute of Oncology (IEO)

Milan, Italy, 20141

RECRUITING

Spain,

Vall d'Hebron University Hospital

Barcelona, Spain, 08035

RECRUITING

Spain,

Catalan Institute of Oncology, L'Hospitalet de Llobregat (ICO)

Barcelona, Spain, 08908

RECRUITING

Spain,

October 12 hospital

Madrid, Spain, 28041

RECRUITING

Spain,

START Madrid

Madrid, Spain, 28050

RECRUITING

Spain,

Hospital University the Policenics The F

Valencia, Spain, 46026

RECRUITING

Spain,

Health Research Institute (Incliva)

Valencia, Spain, 46026