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Sacituzumab Tirumotecan for Pancreatic Cancer

NCT07561463 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-01

No results posted yet for this study

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).

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)

Interventions

DRUG

Sacituzumab tirumotecan

Sacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • LIN YANG, Doctor · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-01-01
Completion
2027-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07561463 on ClinicalTrials.gov