A Prospective Study of Sacituzumab Tirumotecan Plus Pembrolizumab for Advanced Biliary Tract Cancer

NCT07850791 | Recruiting Phase 2 DMC

• 1 other identifier: STADC-BTC
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

Sacituzumab Tirumotecan; Pembrolizumab; Second-line; TROP-2

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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.

Study Arms (1)

sacituzumab tirumotecan combined with pembrolizumab

EXPERIMENTAL

Drug: Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab

Interventions

Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab DRUG

Participants will receive a combination therapy of sacituzumab tirumotecan and pembrolizumab. Sacituzumab tirumotecan will be administered at a dose of 4 mg/kg via intravenous infusion every 2 weeks. Concurrently, pembrolizumab will be administered at a dose of 200 mg via intravenous infusion every 3 weeks. This combination treatment will continue until disease progression or the occurrence of intolerable toxicity.

sacituzumab tirumotecan combined with pembrolizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Haitao Zhao, MD: lead

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Haitao Zhao, DR

CONTACT

+86-10-69156042; zhaoht@pumch.cn

Study Design

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

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: September 30, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 30, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)