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NOT YET RECRUITING
NCT07561463
PHASE2

Sacituzumab Tirumotecan for Pancreatic Cancer

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, open-label Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab govitecan monotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma who have failed at least one prior line of therapy, and to explore the potential correlation between baseline tumor tissue TROP-2 expression and treatment efficacy. The study plans to enroll 30 eligible subjects, who will receive sacituzumab govitecan at 5 mg/kg via intravenous infusion every 2 weeks as one treatment cycle, until disease progression or intolerable toxicity occurs. The primary endpoint is Objective Response Rate (ORR); secondary endpoints include Progression-Free Survival (PFS), Overall Survival (OS), Disease Control Rate (DCR), Duration of Response (DOR), and the incidence and severity of Treatment-Related Adverse Events (TRAEs).

Official title: A Phase II Trial of Sacituzumab Tirumotecan for Previously Treated Locally Advanced or Metastatic Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-04-01

Completion Date

2027-07-01

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab tirumotecan

Sacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks