breast cancer, biliary tract carcinoma, ovarian, endometrial cancer, and squamous non-small cell lung cancer.
Conditions
Brief summary
Incidence of AEs/SAEs, Incidence of DLTs, Changes from baseline in laboratory findings, ECGs and vital signs, Changes in physical examination (including ECOG)
Detailed description
Radiological response evaluated according to RECIST v1.1 - objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS)., Serum concentrations of AZD8205, anti-B7-H4 antibody (INT016) and unconjugated payload (AZ14170132)., Pharmacodynamics (PK) parameters of AZD8205, INT016 and AZ14170132, including but not limited to area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to reach maximum concentration (tmax), clearance and half-life, as data allow., The number and percentage of participants who develop anti-drug antibody (ADAs)., Additional Sub Study 1 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Serum concentrations and PK parameters (where applicable) of rilvegostomig; Incidence of ADAs against rilvegostomig in serum, Additional Sub study 4 secondary endopoints: Plasma concentration and PK parameters of AZD9574 Serum concentrations and PK parameter (where applicable) of rilvegostomig The number and percentage of participants who develop ADAs.
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs/SAEs, Incidence of DLTs, Changes from baseline in laboratory findings, ECGs and vital signs, Changes in physical examination (including ECOG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiological response evaluated according to RECIST v1.1 - objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS)., Serum concentrations of AZD8205, anti-B7-H4 antibody (INT016) and unconjugated payload (AZ14170132)., Pharmacodynamics (PK) parameters of AZD8205, INT016 and AZ14170132, including but not limited to area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to reach maximum concentration (tmax), clearance and half-life, as data allow., The number and percentage of participants who develop anti-drug antibody (ADAs)., Additional Sub Study 1 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Changes in tumor cell γH2AX protein expression on treatment., Additional Sub Study 2 Secondary end points: Serum concentrations and PK parameters (where applicable) of rilvegostomig; Incidence | — |
Countries
Belgium, France, Hungary, Italy, Netherlands, Poland, Spain