Sacituzumab Tirumotecan for Pancreatic Cancer (NCT07561463) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sacituzumab Tirumotecan for Pancreatic Cancer
30 participantsStarted 2026-04-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Voluntary participation with written informed consent provided
✓. Age ≥18 years at the time of signing the informed consent form
✓. Failure of or disease progression after at least one prior line of systemic therapy for locally advanced or metastatic pancreatic cancer
✓. At least one measurable target lesion at baseline per RECIST 1.1 criteria (a single measurable lesion must not have received prior radiotherapy, or must have demonstrated clear progression after radiotherapy)
✓. ECOG performance status score of 0-2
✓. Adequate organ and bone marrow function (including hematologic, hepatic, renal, and coagulation parameters meeting specified criteria)
✓. Subjects of childbearing potential must use highly effective contraception, and female subjects must have a negative pregnancy test
Exclusion criteria
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From the date of first dose to the date of first documented disease progression as assessed by RECIST v1.1, death from any cause, or study discontinuation, whichever occurs first; tumor assessments performed every 6 weeks for up to 100 weeks.
Trial details
NCT IDNCT07561463
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences