OncoMatch/Clinical Trials/NCT07850791
A Prospective Study of Sacituzumab Tirumotecan Plus Pembrolizumab for Advanced Biliary Tract Cancer
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
Is NCT07850791 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab for biliary tract cancer (btc).
Treatment: Sacituzumab Tirumotecan (SKB264) plus Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage IIIA, IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: standard therapy
Disease progression after one or more prior lines of standard therapy.
Cannot have received: TROP2-targeted therapy
Prior treatment with TROP2-targeted therapy
Cannot have received: topoisomerase I inhibitor
Prior treatment with ... topoisomerase I inhibitors
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L. No blood transfusion, no G-CSF administration, and no pharmacological correction within 14 days prior to screening.
Kidney function
Serum creatinine ≤ 1.5x ULN, or creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula).
Liver function
ALT and AST ≤ 2.5x ULN; for patients with liver metastases, ALT and AST ≤ 5x ULN. Serum bilirubin ≤ 2.0x ULN (criteria do not apply to patients with confirmed Gilbert's syndrome). Any clinically significant biliary obstruction must be relieved prior to enrollment.
Adequate hematological and organ function ... see full text for details.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07850791 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior TROP2-targeted therapy, topoisomerase I inhibitor disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIIA or IIIB or IIIC or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages