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ACTIVE NOT RECRUITING
NCT06049212
PHASE1

Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a phase 1 trial of the safety, tolerability, and pharmacokinetics (PK) of sacituzumab tirumotecan monotherapy, and of sacituzumab tirumotecan in combination with pembrolizumab (MK-3475) or pembrolizumab + carboplatin, in Japanese participants with advanced solid tumors or treatment-naïve advanced or metastatic non-small cell lung cancer (NSCLC). Per protocol amendment 04, Arm 3: Pembrolizumab/Carboplatin + sacituzumab tirumotecan Combination Therapy was discontinued, and subsequently all Arm 3 procedures, recruitment, and descriptions were removed.

Official title: Phase 1 Trial of MK-2870 as Monotherapy and in Combination With Pembrolizumab ± Chemotherapy in Subjects With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-10-26

Completion Date

2027-01-29

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

Sacituzumab tirumotecan injection powder for intravenous (IV) infusion.

BIOLOGICAL

Pembrolizumab

Pembrolizumab solution for IV infusion.

DRUG

Supportive care measures

Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions

Locations (7)

Aichi Cancer Center ( Site 0006)

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East ( Site 0002)

Kashiwa, Chiba, Japan

National Hospital Organization Shikoku Cancer Center ( Site 0008)

Matsuyama, Ehime, Japan

Kanagawa Cancer Center ( Site 0004)

Yokohama, Kanagawa, Japan

Kansai Medical University Hospital ( Site 0007)

Hirakata, Osaka, Japan

Shizuoka Cancer Center ( Site 0005)

Nagaizumi-cho,Sunto-gun, Shizuoka, Japan

National Cancer Center Hospital ( Site 0001)

Chuo-ku, Tokyo, Japan