Melanoma Clinical Trial

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

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.

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Full 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:

To identify the maximum tolerated dose (MTD) and pharmacologically effective dose range (PEDR) for CDR404
To assess preliminary evidence of anti-tumor activity of CDR404
To characterise the pharmacokinetics of CDR404
To characterise the immunogenicity of CDR404
To assess translational biomarkers

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT06402201

Recruitment Status:

Not yet recruiting

Sponsor:

CDR-Life AG

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There are 5 Locations for this study

See Locations Near You

University of Miami
Miami Florida, 33136, United States More Info
Lauren Miro
Contact
[email protected]
Gilberto de Lima Lopes, MD
Principal Investigator
University of Michigan
Ann Arbor Michigan, 48109, United States More Info
Cancer Answer Line
Contact
800-865-1125
[email protected]
Paul Swiecicki, MD
Principal Investigator
Providence Cancer Institute
Portland Oregon, 97213, United States More Info
Providence Cancer Institute
Contact
[email protected]
Rom Leidner, MD
Principal Investigator
Pennsylvania Hospital
Philadelphia Pennsylvania, 19106, United States More Info
Research Team
Contact
215-829-7089
[email protected]
Mark Diamond, MD
Principal Investigator
Rigshospitalet
Copenhagen , DK-21, Denmark More Info
Phase 1 Unit
Contact
[email protected]
Iben Spanggaard, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

42

Study ID:

NCT06402201

Recruitment Status:

Not yet recruiting

Sponsor:


CDR-Life AG

How clear is this clinincal trial information?

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