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
Study ID
NCT06049212
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab tirumotecan — BIOLOGICAL
    Sacituzumab tirumotecan injection powder for intravenous (IV) infusion.
  • Pembrolizumab — BIOLOGICAL
    Pembrolizumab solution for IV infusion.
  • Supportive care measures — DRUG
    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

Study Details

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.

Key Dates

Start date
Oct 26, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jan 29, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Sacituzumab tirumotecan Monotherapy
    Participants receive single doses of sacituzumab tirumotecan monotherapy once every 2 weeks (Q2W).
  • Experimental: Arm 2: Pembrolizumab + Sacituzumab tirumotecan Combination Therapy
    Participants receive sacituzumab tirumotecan Q2W in combination with pembrolizumab once every 6 weeks (Q6W).

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicity (DLT) [ Time Frame: Up to 21 days after each dose ]

Related Studies