A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509307-33-00

Acronym

MK-3475-06C

Enrollment

Registered

2024-08-13

Start date

2024-09-26

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Gastroesophageal cancer

Brief summary

Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE), Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE, Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blind Independent Review Committee (BICR)

Detailed description

Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR, Overall Survival (OS), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Incidence of Antidrug Antibodies (ADA) to sacituzumab tirumotecan (sac-TMT, MK-2870)

Interventions

DRUGCALCIUM FOLINATE

DRUG-

DRUGCALCIUM LEVOFOLINATE

DRUGPARACETAMOL

DRUGCAPECITABINE

DRUGMK-2870

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGOXALIPLATIN

DRUGFLUOROURACIL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs), Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE), Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE, Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blind Independent Review Committee (BICR)	—

Measure

Time frame

—

Secondary

Measure	Time frame
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR, Overall Survival (OS), Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Incidence of Antidrug Antibodies (ADA) to sacituzumab tirumotecan (sac-TMT, MK-2870)	—

Countries

France, Germany, Italy, Norway

Outcome results

None listed

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