Sacituzumab Tirumotecan for Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntary participation with written informed consent provided
Age ≥18 years at the time of signing the informed consent form
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)
Failure of or disease progression after at least one prior line of systemic therapy for locally advanced or metastatic pancreatic cancer
Disqualifiers
History of or current presence of central nervous system metastases
Presence of untreated or unstable spinal cord compression
High risk of gastrointestinal or intra-abdominal bleeding
Prior treatment with TROP2-targeted agents or antibody-drug conjugates (ADCs)
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab tirumotecan
DrugSacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDACExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective Response Rate (ORR)
Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST
Time frame
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.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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