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A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517926-25-00
Acronym
MK-6070-002
Enrollment
40
Registered
2025-03-11
Start date
2025-03-12
Completion date
Unknown
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small cell lung cancer

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

DRUGDURVALUMAB
DRUGMK-6070

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026