A Phase 1b/2 Open-label Study Evaluating different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-based regimens in First-line Extensive Stage Small Cell Lung Cancer

Conditions

Small cell lung cancer extensive stage

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, Objective Response Rate (ORR)

Detailed description

Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig (MK-6070), AUCt of Ifinatamab Deruxtecan (I-DXd), AUCt of Deruxtecan (DXd), AUCt of Anti-B7-H3 Antibody, Area Under the Steady-State Concentration-Time Curve Over the Dosing Interval t (AUCt,ss) of Gocatamig, AUCt,ss of I-DXd, AUCt,ss of DXd, AUCt,ss of Anti-B7-H3 Antibody, Maximum Concentration (Cmax) of Gocatamig, Cmax of I-DXd, Cmax of DXd, Cmax of Anti-B7-H3 Antibody, Trough Concentration (Ctrough) of Gocatamig, Ctrough of I-DXd, Ctrough of DXd, Ctrough of Anti-B7-H3 Antibody, Incidence of Anti-Drug Antibodies (ADAs) Against Gocatamig, Incidence of ADAs Against I-DXd

Related papers

No related papers found yet.

Interventions

DRUGATEZOLIZUMAB

DRUGTOCILIZUMAB

DRUGETOPOSIDE

DRUGCARBOPLATIN

DRUGIfinatamab Deruxtecan

DRUGMK-6070

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

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, Objective Response Rate (ORR)	—

Secondary

Measure	Time frame
Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig (MK-6070), AUCt of Ifinatamab Deruxtecan (I-DXd), AUCt of Deruxtecan (DXd), AUCt of Anti-B7-H3 Antibody, Area Under the Steady-State Concentration-Time Curve Over the Dosing Interval t (AUCt,ss) of Gocatamig, AUCt,ss of I-DXd, AUCt,ss of DXd, AUCt,ss of Anti-B7-H3 Antibody, Maximum Concentration (Cmax) of Gocatamig, Cmax of I-DXd, Cmax of DXd, Cmax of Anti-B7-H3 Antibody, Trough Concentration (Ctrough) of Gocatamig, Ctrough of I-DXd, Ctrough of DXd, Ctrough of Anti-B7-H3 Antibody, Incidence of Anti-Drug Antibodies (ADAs) Against Gocatamig, Incidence of ADAs Against I-DXd	—

Measure

Time frame

Disease Control Rate (DCR), Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig (MK-6070), AUCt of Ifinatamab Deruxtecan (I-DXd), AUCt of Deruxtecan (DXd), AUCt of Anti-B7-H3 Antibody, Area Under the Steady-State Concentration-Time Curve Over the Dosing Interval t (AUCt,ss) of Gocatamig, AUCt,ss of I-DXd, AUCt,ss of DXd, AUCt,ss of Anti-B7-H3 Antibody, Maximum Concentration (Cmax) of Gocatamig, Cmax of I-DXd, Cmax of DXd, Cmax of Anti-B7-H3 Antibody, Trough Concentration (Ctrough) of Gocatamig, Ctrough of I-DXd, Ctrough of DXd, Ctrough of Anti-B7-H3 Antibody, Incidence of Anti-Drug Antibodies (ADAs) Against Gocatamig, Incidence of ADAs Against I-DXd

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Outcome results

None listed