Metastatic castration-resistant prostate cancer
Conditions
Brief summary
Incidence and severity of DLTs during Cycle 1 (dose escalation only), Incidence, severity, and relationship of AEs and SAEs, Laboratory parameters, Treatment discontinuations and treatment modifications due to AEs
Detailed description
Plasma concentration profile parameters (AUC, AUClast, AUCtau, Cmax, Tmax, T1/2, and Ctrough) of total ADC, total antibody, and unconjugated exatecan payload, Safety and efficacy endpoints, PSA50 response rate, ORR by investigator assessment, PSA PFS, Radiographic PFS by investigator assessment, Duration of response (PSA and radiographic by investigator assessment), Disease control rate, Overall survival, Prevalence and plasma titers of ADA against TD001
Interventions
DRUGTD001
Sponsors
T.O.A.D. Oncology S.A.
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of DLTs during Cycle 1 (dose escalation only), Incidence, severity, and relationship of AEs and SAEs, Laboratory parameters, Treatment discontinuations and treatment modifications due to AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration profile parameters (AUC, AUClast, AUCtau, Cmax, Tmax, T1/2, and Ctrough) of total ADC, total antibody, and unconjugated exatecan payload, Safety and efficacy endpoints, PSA50 response rate, ORR by investigator assessment, PSA PFS, Radiographic PFS by investigator assessment, Duration of response (PSA and radiographic by investigator assessment), Disease control rate, Overall survival, Prevalence and plasma titers of ADA against TD001 | — |
Countries
France, Spain
Outcome results
None listed