Sacituzumab Tirumotecan for Pancreatic Cancer

NCT07561463 | Not Yet Recruiting Phase 2

• 1 other identifier: NCC6141
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST

  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.

Study Arms (1)

Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDAC

EXPERIMENTAL

Drug: Sacituzumab tirumotecan

Interventions

Sacituzumab tirumotecan DRUG

Sacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks

Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Ability and willingness to comply with study-related procedures.

You may not qualify if:

• 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)
• Requirement for strong CYP3A4 inhibitors or inducers within 2 weeks prior to the first dose, or inability to avoid their use during the study
• History of severe dry eye syndrome, meibomian gland disease, or other corneal disorders that may impair corneal healing
• Major surgery within 28 days prior to the first dose (excluding palliative procedures), or receipt of curative radiotherapy within 3 months
• Presence of other malignancies within 3 years prior to the first treatment (except for certain definitively treated cancers)
• Uncontrolled severe systemic diseases such as cardiovascular or cerebrovascular disease, diabetes mellitus, or hypertension
• History of interstitial lung disease or non-infectious pneumonitis, or current related lesions
• Presence of severe underlying pulmonary disease, autoimmune disease, or prior total pneumonectomy
• Active chronic inflammatory bowel disease, gastrointestinal obstruction, or other severe gastrointestinal disorders
• Tumor invasion of critical organs or vessels with associated symptoms, or risk of fistula formation
• Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (except for low-risk toxicities)
• Active hepatitis B, hepatitis C, HIV infection, or active syphilis

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Officials

• LIN YANG, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIN YANG Doctor

CONTACT

010-13681015148; linyangcicams@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: May 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share