Small cell lung cancer
Conditions
Brief summary
Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Number of Participants Who Discontinue Study Intervention Due to an AE, Part 1: Objective Response Rate (ORR)
Detailed description
Part 1, Part 2 (Arm 5 and Arm 6), and Part 3 (Arm 7): Duration of Response (DOR), Part 1, Part 2 (Arm 6), and Part 3 (Arm 7): Progression-Free Survival (PFS), Part 2 (Arm 5 and Arm 6) and Part 3 (Arm 7): ORR, Maximum Concentration (Cmax) of gocatamig, Cmax of ifinatamab deruxtecan (I-DXd), Cmax of Anti-B7-H3 Antibody, Cmax of Deruxtecan (DXd), Cmax of durvalumab, Time to maximum concentration (Tmax) of gocatamig, Tmax of I-DXd, Tmax of Anti-B7-H3 Antibody, Tmax of DXd, Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig, AUCt of I-DXd, AUCt of Anti-B7-H3 Antibody, AUCt of DXd, erminal Half-Life (t1/2) of gocatamig, t1/2 of I-DXd, t1/2 of Anti-B7-H3 Antibody, t1/2 of DXd, Steady State Maximum Concentration (Cmax,ss) of gocatamig, Cmax,ss of I-DXd, Cmax,ss of Anti-B7-H3 Antibody, Cmax,ss of DXd, Cmax,ss of durvalumab, Steady State Ctrough (Ctrough,ss) of gocatamig, Ctrough,ss of I-DXd, Ctrough,ss of Anti-B7-H3 Antibody, Ctrough,ss of DXd, Ctrough,ss of durvalumab, Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig, Tmax,ss of I-DXd, Tmax,ss of Anti-B7-H3 Antibody, Tmax,ss of DXd, Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig, AUCt,ss of I-DXd, AUCt,ss of Anti-B7-H3 Antibody, AUCt,ss of DXd, 39. Steady state t1/2 (t1/2,ss) of gocatamig, t1/2,ss of I-DXd, t1/2,ss of Anti-B7-H3 Antibody, t1/2,ss of DXd, Accumulation Ratio (AC) of gocatamig, AC of I-DXd, AC of Anti-B7-H3 Antibody, AC of DXd, Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig, Incidence of ADAs Against I-DXd, Incidence of ADAs against durvalumab
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Number of Participants Who Discontinue Study Intervention Due to an AE, Part 1: Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1, Part 2 (Arm 5 and Arm 6), and Part 3 (Arm 7): Duration of Response (DOR), Part 1, Part 2 (Arm 6), and Part 3 (Arm 7): Progression-Free Survival (PFS), Part 2 (Arm 5 and Arm 6) and Part 3 (Arm 7): ORR, Maximum Concentration (Cmax) of gocatamig, Cmax of ifinatamab deruxtecan (I-DXd), Cmax of Anti-B7-H3 Antibody, Cmax of Deruxtecan (DXd), Cmax of durvalumab, Time to maximum concentration (Tmax) of gocatamig, Tmax of I-DXd, Tmax of Anti-B7-H3 Antibody, Tmax of DXd, Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig, AUCt of I-DXd, AUCt of Anti-B7-H3 Antibody, AUCt of DXd, erminal Half-Life (t1/2) of gocatamig, t1/2 of I-DXd, t1/2 of Anti-B7-H3 Antibody, t1/2 of DXd, Steady State Maximum Concentration (Cmax,ss) of gocatamig, Cmax,ss of I-DXd, Cmax,ss of Anti-B7-H3 Antibody, Cmax,ss of DXd, Cmax,ss of durvalumab, Steady State Ctrough (Ctrough,ss) of gocatamig, Ctrough,ss of I-DXd, Ctrough,ss of Anti-B7-H3 Antibody, Ctrough,ss of DXd, Ctrough,ss of | — |
Countries
Spain