Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT07561463
Sacituzumab Tirumotecan for Pancreatic Cancer
A Phase 2 study testing Sacituzumab tirumotecan in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- Sacituzumab tirumotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
- Known allergy to the investigational drug or its components, or history of severe hypersensitivity to other biologic agents
- Severe infection within 4 weeks prior to dosing, or active infection requiring systemic therapy within 2 weeks
- Receipt of non-specific immunomodulatory therapy or antitumor traditional Chinese medicine within 2 weeks prior to dosing
- Receipt of live vaccines within 30 days prior to dosing or planned during the study period
- Pregnant or breastfeeding women, or individuals of childbearing potential who are not using highly effective contraception as required
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- Sacituzumab tirumotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecanDrug
Sacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDAC | Experimental | Not described Receives: Drug: Sacituzumab tirumotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIN YANG, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- LIN YANG, Doctor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561463
- Sponsor's protocol ID
- NCC6141
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Sacituzumab Tirumotecan for Previously Treated Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07561463
- Acronym / sponsor ID
- NCC6141
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDAC | Experimental | Drug: Sacituzumab tirumotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab tirumotecanSacituzumab tirumotecan 5 mg/kg administered intravenously every 2 weeks | Drug | Sacituzumab tirumotecan in Previously Treated Locally Advanced or Metastatic PDAC |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
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RecruitingPhase 3
Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LIN YANG, Doctor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab tirumotecan in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LIN YANG Doctor (010-13681015148, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.