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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
IV infusions
University of Miami
Miami, Florida, United States
RECRUITINGUniversity of Michigan
Presence of dose limiting toxicities (DLTs)
per Protocol
Time frame: From first dose to DLT period (21 days)
Incidence and severity of (serious) adverse events ([S]AEs)
AEs, SAEs
Time frame: From first dose to 90 days after the last dose
Anti-tumor response: Overall Response Rate (ORR)
per RECIST 1.1
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
Disease control rate (DCR)
per RECIST 1.1
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
Duration of response (DOR)
per RECIST 1.1
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
Progression-free Survival (PFS)
per RECIST 1.1
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
Overall Survival (OS)
per RECIST 1.1
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
Dimitrios Chondros Chief Medical Officer, CDR-Life
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ann Arbor, Michigan, United States
Providence Cancer Institute
Portland, Oregon, United States
RECRUITINGPennsylvania Hospital
Philadelphia, Pennsylvania, United States
RECRUITINGUniversitair Ziekenhuis Antwerpen
Antwerp, Belgium
RECRUITINGInstitut Jules Bordet
Brussels, Belgium
RECRUITINGCliniques Universitaires Saint-Luc, UCL Ouvain
Brussels, Belgium
RECRUITINGUniversitair Ziekenhuis Gent
Ghent, Belgium
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGIstituto Clinico Humanitas
Milan, Italy
RECRUITING...and 8 more locations
Maximum serum concentration of CDR404 (Cmax)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Time to maximum serum concentration of CDR404 (Tmax)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Trough serum concentration of CDR404 (Ctrough)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Half-life of CDR404 (t1/2)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Area under the CDR404 serum concentration over time curve (AUC0-T)
to the end of the dosing interval following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Volume of CDR404 distribution (Vd)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Average serum concentration of CDR404 (Cavg)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Serum drug levels of CDR404 at steady state (CL)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Accumulation ratio of CDR404 (Rac)
following single and multiple dose administration
Time frame: At the end of Cycle 1 and Cycle 2 (each cycle is 21 days)
Immunogenicity
Incidence of detectable anti-CDR404 antibodies (ADAs)
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