Advanced Biliary Tract CancersPhase 2NCT07729033
A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.
A Phase 2 study testing Sacituzumab tirumotecan combined with envafolimab in people with Advanced Biliary Tract Cancers, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, Phase II study evaluating sacituzumab tirumotecan combined with envafolimab in patients with TROP2-positive advanced biliary tract cancers who have progressed on first-line immunochemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Biliary Tract Cancers
- What is being tested?
- Sacituzumab tirumotecan combined with envafolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Jul 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form, regardless of gender;
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer);
- Have received first-line PD-1/PD-L1 inhibitor combined with chemotherapy and have experienced disease progression during or after systemic therapy;
- TROP2 immunohistochemistry score of 2+ or 3+;
- At least one measurable lesion per RECIST v1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to dosing;
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- Life expectancy ≥ 12 weeks;
- Adequate organ and bone marrow function (without blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to dosing), defined as follows:
- Hematology: absolute neutrophil count (NEUT#) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 100 × 10⁹/L; hemoglobin ≥ 90 g/L;
- Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with baseline liver metastases, ALT and AST ≤ 5 × ULN; albumin ≥ 30 g/L; total bilirubin (TBIL) ≤ 1.5 × ULN;
- Renal function: creatinine clearance ≥ 50 mL/min (calculated using the standard Cockcroft-Gault formula);
- Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN;
- Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraceptive measures from the signing of the informed consent form through 6 months after the last dose ;
- Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with protocol-specified visits and related procedures.
Who cannot join
- Prior receipt of any of the following treatments (including in the adjuvant/neoadjuvant setting):
- TROP2-targeted therapy;
- Any drug targeting topoisomerase I, including antibody-drug conjugate (ADC) therapy;
- Use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose or during the study period (use of strong CYP3A4 inhibitors or inducers is not permitted in this study; representative drugs are listed in Appendix 7); all subjects must avoid concomitant use of any known CYP3A4-inducing drugs, herbal supplements, and/or consumption of such foods;
- Documented history of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal disease that impairs/delays corneal healing;
- History of or current central nervous system (CNS) metastases;
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- Other malignancy within 3 years prior to dosing (except for tumors cured by local therapy, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);
- Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors:
- Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Grade 3 or 4 heart failure (per New York Heart Association [NYHA] classification), symptomatic or poorly controlled severe arrhythmias, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular diseases within 6 months prior to dosing;
- History of myocarditis, primary cardiomyopathy, specific cardiomyopathy, or other myocardial diseases;
- Any deep vein thrombosis (subjects may be enrolled if stable on low-molecular-weight heparin or similar therapeutic agents for ≥ 2 weeks), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events within 3 months prior to dosing;
- Aortic aneurysm, aortic dissecting aneurysm, or other major vascular diseases that may be life-threatening or require surgery within 6 months prior to dosing;
- Uncontrolled systemic diseases per investigator judgment:
- Poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L on two consecutive occasions);
- Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg);
- Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (> 1 time/week);
- History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening;
- Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding;
- Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 (per NCI CTCAE v5.0) or to the levels specified in the eligibility criteria (excluding toxicities deemed by the investigator to have low safety risk, such as alopecia and fatigue);
- Active autoimmune disease requiring systemic treatment within the past 2 years, including disease-modifying antirheumatic drugs, immunosuppressants, or systemic corticosteroids (> 10 mg/day prednisone or equivalent). Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy; subjects receiving systemic corticosteroids > 10 mg/day prednisone or other immunosuppressive agents within 2 weeks prior to dosing;
- Known active pulmonary tuberculosis. Subjects with suspected active pulmonary tuberculosis must undergo clinical examination to rule it out;
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Active hepatitis B [hepatitis B surface antigen (HBsAg)-positive, with HBV-DNA ≥ 500 IU/mL or above the lower limit of detection, whichever is higher] or active hepatitis C (hepatitis C antibody-positive with HCV-RNA above the lower limit of detection). Note: HBsAg-positive subjects are required to receive anti-HBV therapy during the study treatment period;
- Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
- Known allergy to the study drug or any of its components, or history of severe hypersensitivity reactions to other biological agents;
- Major surgery within 4 weeks prior to dosing, or expected to require major surgery during the study period;
- Severe infection within 4 weeks prior to dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to dosing;
- Receipt of non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or proprietary Chinese medicine preparations approved for anti-tumor indications within 2 weeks prior to dosing;
- Vaccination with live vaccine within 30 days prior to dosing, or planned vaccination with live vaccine during the study period;
- Rapid deterioration of disease during the screening period prior to dosing, such as significant changes in performance status;
- Pregnant or breastfeeding women;
- Local or systemic diseases unrelated to malignancy, or diseases or symptoms secondary to tumor, that may confer high medical risk and/or uncertainty in survival assessment, such as leukemoid reaction, cachexia, etc.;
- Any condition that, in the investigator's opinion, would interfere with the evaluation of the study drug, subject safety, or interpretation of study results, or any other condition deemed by the investigator as inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
About this study
This is a prospective, single-arm, Phase II study evaluating sacituzumab tirumotecan combined with envafolimab in patients with TROP2-positive advanced biliary tract cancers who have progressed on first-line immunochemotherapy. Up to 28 eligible patients will be enrolled.After screening, eligible patients receive sacituzumab tirumotecan (5 mg/kg IV, d1, Q2W) plus envafolimab (300 mg SC, d1, Q2W) for 3 cycles, with subsequent treatment at the investigator's discretion.
Tumor imaging assessments per RECIST v1.1 are performed at Week 6, then every 6 weeks (up to 48 weeks) and every 12 weeks (thereafter) until disease progression, new therapy, loss to follow-up, or death. Post-treatment survival follow-up is conducted by phone every 3 months.
Read more
The study includes a safety run-in (6 patients) followed by an expansion phase using Simon's two-stage design (first stage: 15 patients; second stage: total 28 patients). The safety run-in stops if >2 DLTs occur; expansion proceeds if ≤2 DLTs. The trial is terminated if ≤1 objective response is observed in the first 15 expansion patients.
The primary endpoint is ORR(investigator-assessed per RECIST v1.1). Secondary endpoints include OS, PFS, DCR, DOR, safety, and tolerability.
- Conditions
- Advanced Biliary Tract Cancers
- Being tested
- Sacituzumab tirumotecan combined with envafolimab
- Keywords
- antibody-drug conjugate, Biliary Tract Cancers, TROP2, immunotherapy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab tirumotecan combined with envafolimabDrug
Sacituzumab tirumotecan 5 mg/kg, administered intravenously (IV) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Envafolimab 300 mg, administered subcutaneously (SC) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Subsequent treatment decisions will be made by the investigator based on comprehensive efficacy assessments.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab tirumotecan combined with envafolimab | Experimental | Sacituzumab tirumotecan 5 mg/kg, administered intravenously (IV) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Envafolimab 300 mg, administered subcutaneously (SC) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Subsequent treatment decisions will be made by the investigator based on comprehensive efficacy assessments. Receives: Drug: Sacituzumab tirumotecan combined with envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate (ORR) of sacituzumab tirumotecan combined with envafolimab in TROP2-positive advanced biliary tract cancers previously treated with first-line immunotherapy combined with chemotherapy, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Measured: 1 year
Secondary outcomes (5)
OS
Overall survival (OS) of sacituzumab tirumotecan combined with envafolimab in TROP2-positive advanced biliary tract cancers previously treated with first-line immunotherapy combined with chemotherapy;
Measured: 3 years
PFS
Progression-free survival (PFS) of sacituzumab tirumotecan combined with envafolimab in TROP2-positive advanced biliary tract cancers previously treated with first-line immunotherapy combined with chemotherapy, as assessed by the investigator per RECIST v1.1
Measured: 2 years
DCR
Disease control rate (DCR) of sacituzumab tirumotecan combined with envafolimab in TROP2-positive advanced biliary tract cancers previously treated with first-line immunotherapy combined with chemotherapy, as assessed by the investigator per RECIST v1.1;
Measured: 1 year
DOR
Duration of response (DOR) of sacituzumab tirumotecan combined with envafolimab in TROP2-positive advanced biliary tract cancers previously treated with first-line immunotherapy combined with chemotherapy, as assessed by the investigator per RECIST v1.1;
Measured: 2 years
Safety
The incidence and severity of adverse events (evaluated according to NCI CTCAE v5.0)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Biliary Tract CancersStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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
- 28 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729033
- Sponsor's protocol ID
- SKB264-NSIP-028
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.
- ClinicalTrials.gov ID
- NCT07729033
- Acronym / sponsor ID
- SKB264-NSIP-028
- Conditions
- Advanced Biliary Tract Cancers
- Keywords
- antibody-drug conjugate, Biliary Tract Cancers, TROP2, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Jul 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 prospective, single-arm, Phase II study evaluating sacituzumab tirumotecan combined with envafolimab in patients with TROP2-positive advanced biliary tract cancers who have progressed on first-line immunochemotherapy. Up to 28 eligible patients will be enrolled.After screening, eligible patients receive sacituzumab tirumotecan (5 mg/kg IV, d1, Q2W) plus envafolimab (300 mg SC, d1, Q2W) for 3 cycles, with subsequent treatment at the investigator's discretion.
Tumor imaging assessments per RECIST v1.1 are performed at Week 6, then every 6 weeks (up to 48 weeks) and every 12 weeks (thereafter) until disease progression, new therapy, loss to follow-up, or death. Post-treatment survival follow-up is conducted by phone every 3 months.
The study includes a safety run-in (6 patients) followed by an expansion phase using Simon's two-stage design (first stage: 15 patients; second stage: total 28 patients). The safety run-in stops if >2 DLTs occur; expansion proceeds if ≤2 DLTs. The trial is terminated if ≤1 objective response is observed in the first 15 expansion patients.
The primary endpoint is ORR(investigator-assessed per RECIST v1.1). Secondary endpoints include OS, PFS, DCR, DOR, safety, and tolerability.
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 combined with envafolimab | Experimental | Drug: Sacituzumab tirumotecan combined with envafolimabSacituzumab tirumotecan 5 mg/kg, administered intravenously (IV) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Envafolimab 300 mg, administered subcutaneously (SC) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Subsequent treatment decisions will be made by the investigator based on comprehensive efficacy assessments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form, regardless of gender;
- Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer);
- Have received first-line PD-1/PD-L1 inhibitor combined with chemotherapy and have experienced disease progression during or after systemic therapy;
- TROP2 immunohistochemistry score of 2+ or 3+;
- At least one measurable lesion per RECIST v1.1;
Key exclusion criteria (33 listed)
- Prior receipt of any of the following treatments (including in the adjuvant/neoadjuvant setting):
- Use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose or during the study period (use of strong CYP3A4 inhibitors or inducers is not permitted in this study; representative drugs are listed in Appendix 7); all subjects must avoid concomitant use of any known CYP3A4-inducing drugs, herbal supplements, and/or consumption of such foods;
- Documented history of severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal disease that impairs/delays corneal healing;
- History of or current central nervous system (CNS) metastases;
- Other malignancy within 3 years prior to dosing (except for tumors cured by local therapy, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);
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 tirumotecan combined with envafolimabSacituzumab tirumotecan 5 mg/kg, administered intravenously (IV) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Envafolimab 300 mg, administered subcutaneously (SC) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Subsequent treatment decisions will be made by the investigator based on comprehensive efficacy assessments. | Drug | Sacituzumab tirumotecan combined with envafolimab |
Primary outcome
ORR
Time frame: 1 year
Objective response rate (ORR) of sacituzumab tirumotecan combined with envafolimab in TROP2-positive advanced biliary tract cancers previously treated with first-line immunotherapy combined with chemotherapy, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
5 secondary outcomes
OS
Time frame: 3 years
PFS
Time frame: 2 years
DCR
Time frame: 1 year
DOR
Time frame: 2 years
Safety
Time frame: 3 years
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 27 Jul 2026.
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Biliary Tract Cancer, Cholangiocarcinoma
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At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
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RecruitingPhase 2
Gemcitabine, Cisplatin, Nab-paclitaxel (GAP) and Cemiplimab for Locally Advanced Biliary Tract Cancer (BTC)
Colon and Rectal Cancer
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MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab tirumotecan combined with envafolimab in people with Advanced Biliary Tract Cancers, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 14 inclusion and 33 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 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Huikai Li (+86 18622228639, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 1 year). 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 27 Jul 2026.