NCT06049212 · ClinicalTrials.gov record · last posted 2026-08-06
Sacituzumab Tirumotecan (MK-2870) as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors (MK-2870-008)
Study acronym: TroFuse-008
StatusActive, Not Recruiting
PhasePhase 1
Started2023-10-26
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.
Protocol amendment history
1 change detected by DataLookout
2026-08-07
critical
Primary completion pushed: 2026-06-30 → 2026-12-31
| NCT Number |
NCT06049212 |
| Lead Sponsor |
Merck Sharp & Dohme LLC
|
| 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) |
| Enrollment |
30 participants |
| Start Date |
2023-10-26 |
| Primary Completion |
2026-12-31 (estimated) |
| Study Completion |
2027-01-29 (estimated) |
| Updated on ClinicalTrials.gov |
2026-08-06 |