NCT06049212

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer
• Solid Tumors
• Programmed Cell Death-1 (PD1, PD-1)
• Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
• Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-10-26
• Primary completion: 2026-06-30
• Completion: 2027-01-29
• First posted: 2023-09-22
• Last updated: 2026-04-16

Locations

7 sites across 1 country: Japan