Biliary Tract Cancer (BTC)Phase 2NCT07850791
A Prospective Study of Sacituzumab Tirumotecan Plus Pembrolizumab for Advanced Biliary Tract Cancer
A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) and Pembrolizumab in people with Biliary Tract Cancer (BTC), run by Haitao Zhao, MD at 1 site in China.
Trial summary
The purpose of this study is to explore the effects of sacituzumab tirumotecan combined with pembrolizumab on survival, disease progression, and safety in patients with advanced biliary tract malignancies in the second-line and later settings. This is a multicenter, phase II, interventional single-arm clinical study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer (BTC)
- What is being tested?
- Sacituzumab Tirumotecan (SKB264) and Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Dec 2029
- 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
- Subjects must voluntarily participate in the study, sign a written informed consent form (ICF), demonstrate good compliance, and cooperate with follow-up visits. Subjects must be $\ge$ 18 and < 75 years of age at the time of signing the ICF, with no gender restrictions.
- Histologically and radiologically confirmed advanced biliary tract cancer (BTC) that is unresectable, recurrent, locally advanced, or metastatic, defined as Stage IIIA or higher according to the AJCC 8th edition staging system, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- Disease progression after one or more prior lines of standard therapy.
- Ineligible for radical surgery/local therapy for at least 4 weeks prior to baseline assessment, or experienced disease progression thereafter. The aforementioned treatments include lesion resection, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiotherapy, etc. All acute toxicities from local therapy must have resolved to ≤ Grade 1 per CTCAE v5.0.
- Presence of at least one measurable lesion (according to RECIST v1.1, the measurable lesion must have a longest diameter ≥ 10 mm by spiral CT scan, or a short axis ≥ 15 mm for enlarged lymph nodes).
- ECOG performance status of 0 or 1 within 1 week prior to enrollment. Estimated life expectancy of ≥ 3 months as assessed by the investigator.
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- Adequate hematological and organ function, based on the following laboratory results obtained within 14 days prior to the initiation of study treatment (unless otherwise specified):
- Hematology: (No blood transfusion, no G-CSF administration, and no pharmacological correction within 14 days prior to screening) Hemoglobin (Hb) ≥ 90 g/L; Absolute Neutrophil Count (ANC) ≥ 1.5 10^9/L; Platelets (PLT) ≥100 10^9/L.
- Biochemistry: (No albumin transfusion within 14 days) Adequate liver function: ALT and AST ≤ 2.5 $\times$ Upper Limit of Normal (ULN); for patients with liver metastases, ALT and AST ≤ 5 ULN.
- Serum bilirubin ≤ 2.0 ULN; these criteria do not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction must be relieved prior to enrollment.
- Adequate renal function: Serum creatinine ≤ 1.5 * ULN, or creatinine clearance (CrCl) > 50 mL/min (calculated using the standard Cockcroft-Gault formula):
- Female: CrCl = ((140 - Age) Weight (kg) 0.85) / (72 Serum Creatinine (mg/dL)); Male: CrCl = ((140 - Age) Weight (kg) 1.00) / (72 Serum Creatinine (mg/dL)).
- Women of childbearing potential: Must agree to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with an annual failure rate of < 1% during the treatment period and for at least 6 months after the last dose of study medication.
- Males: Must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree not to donate sperm.
Who cannot join
- Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors.
- Patients currently receiving approved or investigational systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or traditional Chinese medicine with specific anti-cancer indications. (Such treatments are permitted if completed at least 4 weeks prior to enrollment).
- Histopathological findings indicating mixed hepatocellular cholangiocarcinoma, the presence of squamous cell carcinoma or sarcomatoid components, or ampullary carcinoma.
- Presence of other uncured malignancies within the past 5 years (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).
- Clinically significant gastrointestinal diseases.
- Clinically significant cardiovascular or cerebrovascular diseases.
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- Hepatic or renal insufficiency:
- Hepatic insufficiency: e.g., presence of jaundice, ascites, and/or bilirubin > 3 ULN.
- Renal insufficiency: Urine protein-to-creatinine ratio > 3.5 g/24 hours, routine urinalysis showing proteinuria ≥ ++, confirmed 24-hour urine protein > 1.0 g, or renal failure requiring hemodialysis or peritoneal dialysis.
- Received strong CYP3A4 inhibitors within 7 days prior to study entry, or strong CYP3A4 inducers within 12 days prior to study entry.
- Active autoimmune disease, a history of autoimmune disease, or risk of immune-mediated diseases:
- Active Hepatitis B [Hepatitis B surface antigen (HBsAg) positive, requiring HBV-DNA testing; HBV-DNA ≥ 500 IU/mL or above the lower limit of detection (LLOD), whichever is higher] or Hepatitis C (HCV antibody positive, and HCV-RNA above the LLOD). Note: Subjects who are HBsAg positive are required to receive anti-HBV therapy during the study treatment period.
- Neurological diseases:
- Patients with epilepsy requiring pharmacological treatment. Known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases who have stable brain metastatic disease (no evidence of progression on imaging for at least 4 weeks prior to the first study treatment, and any neurological symptoms have returned to baseline) are eligible to participate, provided there is no evidence of new or enlarging brain metastases, and they have not used steroids for at least 7 days prior to study treatment. However, patients with carcinomatous meningitis are excluded regardless of clinical stability.
- Presence of an ongoing or active infection.
- Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that may interfere with or delay corneal healing.
- Pregnant or lactating women.
- Any condition that, in the opinion of the investigator, would interfere with the evaluation of the study drug, subject safety, or the interpretation of study results, or any other condition rendering the subject unsuitable for participation in the 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, 1 recruiting
- Recruiting
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100730
Haitao Zhao, DR, +86-10-69156042, zhaoht@pumch.cn
About this study
Official title: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study of Sacituzumab Tirumotecan Plus Pembrolizumab as Second-Line Treatment for Advanced Biliary Tract Cancer
The purpose of this study is to explore the effects of sacituzumab tirumotecan combined with pembrolizumab on survival, disease progression, and safety in patients with advanced biliary tract malignancies in the second-line and later settings. This is a multicenter, phase II, interventional single-arm clinical study. A total of 38 participants will be enrolled. Participants will receive the combination therapy until disease progression or unacceptable toxicity.
- Conditions
- Biliary Tract Cancer (BTC)
- Being tested
- Sacituzumab Tirumotecan (SKB264), Pembrolizumab
- Keywords
- Sacituzumab Tirumotecan, Pembrolizumab, Second-line, TROP-2
- 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 (SKB264)Drug
Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion every 2 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met.
PembrolizumabDrug
Pembrolizumab will be administered at a fixed dose of 200 mg via intravenous infusion every 3 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met.
| Study group | Role | What they receive |
|---|---|---|
| sacituzumab tirumotecan combined with pembrolizumab | Experimental | Not described Receives: Drug: Sacituzumab Tirumotecan (SKB264); Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by investigators. Tumor assessments will be performed approximately every 6 weeks during the first year, and every 8-12 weeks thereafter.
Measured: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.
Secondary outcomes (8)
Disease control rate
Proportion of participants with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) according to RECIST version 1.1, as assessed by investigators. Tumor assessments will be performed approximately every 6 weeks during the first year, and every 8-12 weeks thereafter.
Measured: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.
Progression-Free Survival
Progression-Free Survival is defined as the time from the date of first study drug administration to the first occurrence of disease progression according to RECIST version 1.1, as assessed by investigators, or death from any cause.
Measured: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.
Overall Survival
Overall survival is defined as the time from the date of first study drug administration to death from any cause.
Measured: From the date of first study drug administration until the date of death from any cause or the date of last valid follow-up, whichever came first, assessed up to approximately 24 months.
Duration of Response
Duration of response is defined as the time from the date of the first documented CR or PR to the date of the first documented disease progression according to RECIST version 1.1 or death from any cause.
Measured: From the date of first documented CR or PR until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.
Clinical Benefit Rate
Proportion of participants who achieve CR, PR, or durable stable disease (SD) lasting for a predefined duration (e.g., ≥24 weeks) according to RECIST version 1.1.
Measured: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.
Progression-Free Survival rate at 3 and 6 months
The proportion of participants who remain alive and progression-free at 3 months and 6 months after the first study drug administration, according to RECIST version 1.1.
Measured: At 3 months and 6 months after the first study drug administration.
Mortality rate at 6 and 12 months
The proportion of participants who have died from any cause at 6 months and 12 months after the first study drug administration.
Measured: At 6 months and 12 months after the first study drug administration.
Incidence of Adverse Events
Safety and tolerability will be evaluated by assessing the incidence, type, and severity of adverse events, treatment-related adverse events, serious adverse events, and clinically significant abnormalities in laboratory test results and vital signs. Adverse events will be graded according to NCI CTCAE version 5.0.
Measured: From the date of first study drug administration until 90 days after the date of last study drug administration, with all adverse events monitored and documented continuously.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Cancer (BTC)Studies of the same condition, open and under way.
- 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haitao Zhao, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haitao Zhao, MD, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850791
- Sponsor's protocol ID
- STADC-BTC
- Status last verified
- Aug 2026
- First submitted
- 23 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-Arm, Phase II Clinical Study of Sacituzumab Tirumotecan Plus Pembrolizumab as Second-Line Treatment for Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT07850791
- Acronym / sponsor ID
- STADC-BTC
- Conditions
- Biliary Tract Cancer (BTC)
- Keywords
- Sacituzumab Tirumotecan, Pembrolizumab, Second-line, TROP-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Haitao Zhao, MDUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Sep 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.
The purpose of this study is to explore the effects of sacituzumab tirumotecan combined with pembrolizumab on survival, disease progression, and safety in patients with advanced biliary tract malignancies in the second-line and later settings. This is a multicenter, phase II, interventional single-arm clinical study. A total of 38 participants will be enrolled. Participants will receive the combination therapy until disease progression or unacceptable toxicity.
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 pembrolizumab | Experimental | Drug: Sacituzumab Tirumotecan (SKB264), Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must voluntarily participate in the study, sign a written informed consent form (ICF), demonstrate good compliance, and cooperate with follow-up visits. Subjects must be $\ge$ 18 and < 75 years of age at the time of signing the ICF, with no gender restrictions.
- Histologically and radiologically confirmed advanced biliary tract cancer (BTC) that is unresectable, recurrent, locally advanced, or metastatic, defined as Stage IIIA or higher according to the AJCC 8th edition staging system, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- Disease progression after one or more prior lines of standard therapy.
- Ineligible for radical surgery/local therapy for at least 4 weeks prior to baseline assessment, or experienced disease progression thereafter. The aforementioned treatments include lesion resection, ablation, transarterial chemoembolization (TACE), hepatic arterial infusion chemotherapy (HAIC), radiotherapy, etc. All acute toxicities from local therapy must have resolved to ≤ Grade 1 per CTCAE v5.0.
- Presence of at least one measurable lesion (according to RECIST v1.1, the measurable lesion must have a longest diameter ≥ 10 mm by spiral CT scan, or a short axis ≥ 15 mm for enlarged lymph nodes).
Key exclusion criteria (18 listed)
- Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors.
- Patients currently receiving approved or investigational systemic anti-cancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or traditional Chinese medicine with specific anti-cancer indications. (Such treatments are permitted if completed at least 4 weeks prior to enrollment).
- Histopathological findings indicating mixed hepatocellular cholangiocarcinoma, the presence of squamous cell carcinoma or sarcomatoid components, or ampullary carcinoma.
- Presence of other uncured malignancies within the past 5 years (excluding cured basal cell carcinoma of the skin and cervical carcinoma in situ).
- Clinically significant gastrointestinal diseases.
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 (SKB264)Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion every 2 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met. | Drug | sacituzumab tirumotecan combined with pembrolizumab |
| PembrolizumabPembrolizumab will be administered at a fixed dose of 200 mg via intravenous infusion every 3 weeks. The treatment will continue until documented disease progression, occurrence of unacceptable toxicity, withdrawal of consent, or other protocol-specified criteria for discontinuation are met. | Drug | sacituzumab tirumotecan combined with pembrolizumab |
Primary outcome
Objective response rate
Time frame: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.
Proportion of participants with a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1, as assessed by investigators. Tumor assessments will be performed approximately every 6 weeks during the first year, and every 8-12 weeks thereafter.
8 secondary outcomes
Disease control rate
Time frame: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.
Progression-Free Survival
Time frame: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.
Overall Survival
Time frame: From the date of first study drug administration until the date of death from any cause or the date of last valid follow-up, whichever came first, assessed up to approximately 24 months.
Duration of Response
Time frame: From the date of first documented CR or PR until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months.
Clinical Benefit Rate
Time frame: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.
Progression-Free Survival rate at 3 and 6 months
Time frame: At 3 months and 6 months after the first study drug administration.
Mortality rate at 6 and 12 months
Time frame: At 6 months and 12 months after the first study drug administration.
Incidence of Adverse Events
Time frame: From the date of first study drug administration until 90 days after the date of last study drug administration, with all adverse events monitored and documented continuously.
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 5 Oct 2026.
- Individual participant dataSharing planned: No
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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.
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 (SKB264) and Pembrolizumab in people with Biliary Tract Cancer (BTC), run by Haitao Zhao, MD 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 18 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: looking for participants now, as of the sponsor's last update on 5 Oct 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 Haitao Zhao, DR (+86-10-69156042, zhaoht@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From the date of first study drug administration until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months.). 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 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.