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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDR404 | Experimental | Dose escalation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDR404 | Biological | IV infusions |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate (DCR) | 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 |
| Duration of response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitrios Chondros Chief Medical Officer, CDR-Life | Contact | +41 44 515 7025 | CDR404-001_Study@CDR-Life.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Recruiting | Miami | Florida | 33136 | United States |
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IV dose escalation
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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 |
| Progression-free Survival (PFS) | 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 |
| Overall Survival (OS) | 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 |
| Maximum serum concentration of CDR404 (Cmax) | following single and multiple dose administration | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | At the end of Cycle 1 and Cycle 2 (each cycle is 21 days) |
| Immunogenicity | Incidence of detectable anti-CDR404 antibodies (ADAs) | From first dose until date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months |
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Providence Cancer Institute | Recruiting | Portland | Oregon | 97213 | United States |
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| Pennsylvania Hospital | Recruiting | Philadelphia | Pennsylvania | 19106 | United States |
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| Universitair Ziekenhuis Antwerpen | Recruiting | Antwerp | 2650 | Belgium |
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| Institut Jules Bordet | Recruiting | Brussels | 1070 | Belgium |
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| Cliniques Universitaires Saint-Luc, UCL Ouvain | Recruiting | Brussels | 1200 | Belgium |
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| Universitair Ziekenhuis Gent | Recruiting | Ghent | 9000 | Belgium |
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| Rigshospitalet | Recruiting | Copenhagen | DK-2100 | Denmark |
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| Istituto Clinico Humanitas | Recruiting | Milan | 20089 | Italy |
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| Isituto Europeo di Oncologia (IEO) | Recruiting | Milan | 20141 | Italy |
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| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
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| Institut Catala d'Oncologia, L'Hospitalet de Llobregat (ICO) | Recruiting | Barcelona | 08908 | Spain |
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| Hospital 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| START Madrid | Recruiting | Madrid | 28050 | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| Instituto de Investigacion Sanitaria (INCLIVA) | Recruiting | Valencia | 46026 | Spain |
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| Royal Marsden Hospital | Recruiting | Sutton | London | SM2 5PT | United Kingdom |
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