Sacituzumab Tirumotecan for Pancreatic Cancer

April 28, 2026 updated by: LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntary participation with written informed consent provided
  2. Age ≥18 years at the time of signing the informed consent form
  3. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (including adenosquamous carcinoma)
  4. Failure of or disease progression after at least one prior line of systemic therapy for locally advanced or metastatic pancreatic cancer
  5. 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)
  6. ECOG performance status score of 0-2
  7. Adequate organ and bone marrow function (including hematologic, hepatic, renal, and coagulation parameters meeting specified criteria)
  8. Subjects of childbearing potential must use highly effective contraception, and female subjects must have a negative pregnancy test
  9. Ability and willingness to comply with study-related procedures.

Exclusion Criteria:

  1. History of or current presence of central nervous system metastases
  2. Presence of untreated or unstable spinal cord compression
  3. High risk of gastrointestinal or intra-abdominal bleeding
  4. Prior treatment with TROP2-targeted agents or antibody-drug conjugates (ADCs)
  5. Requirement for strong CYP3A4 inhibitors or inducers within 2 weeks prior to the first dose, or inability to avoid their use during the study
  6. History of severe dry eye syndrome, meibomian gland disease, or other corneal disorders that may impair corneal healing
  7. Major surgery within 28 days prior to the first dose (excluding palliative procedures), or receipt of curative radiotherapy within 3 months
  8. Presence of other malignancies within 3 years prior to the first treatment (except for certain definitively treated cancers)
  9. Uncontrolled severe systemic diseases such as cardiovascular or cerebrovascular disease, diabetes mellitus, or hypertension
  10. History of interstitial lung disease or non-infectious pneumonitis, or current related lesions
  11. Presence of severe underlying pulmonary disease, autoimmune disease, or prior total pneumonectomy
  12. Active chronic inflammatory bowel disease, gastrointestinal obstruction, or other severe gastrointestinal disorders
  13. Tumor invasion of critical organs or vessels with associated symptoms, or risk of fistula formation
  14. Toxicities from prior antitumor therapy not recovered to ≤ Grade 1 (except for low-risk toxicities)
  15. Active hepatitis B, hepatitis C, HIV infection, or active syphilis
  16. Known allergy to the investigational drug or its components, or history of severe hypersensitivity to other biologic agents
  17. Severe infection within 4 weeks prior to dosing, or active infection requiring systemic therapy within 2 weeks
  18. Receipt of non-specific immunomodulatory therapy or antitumor traditional Chinese medicine within 2 weeks prior to dosing
  19. Receipt of live vaccines within 30 days prior to dosing or planned during the study period
  20. Pregnant or breastfeeding women, or individuals of childbearing potential who are not using highly effective contraception as required
  21. Individuals considered vulnerable populations (e.g., patients with psychiatric disorders or critically ill patients), or any other condition deemed unsuitable for enrollment by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDAC
Drug: Sacituzumab tirumotecan
Sacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: LIN YANG, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NCC6141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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