OncoMatch/Clinical Trials/NCT07105852
Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma
Is NCT07105852 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Sacituzumab tirumotecan (iv)+Putolizumab for cholangiocarcinoma.
Treatment: Sacituzumab tirumotecan (iv)+Putolizumab — 1. Primary Objectives (1) To evaluate the safety and tolerability of sacituzumab tirumotecan in combination with pucotenlimab in patients with advanced cholangiocarcinoma; (2) To assess the objective response rate (ORR) of sacituzumab tirumotecan combined with pucotenlimab in patients with unresectable or metastatic cholangiocarcinoma, as evaluated by investigators per RECIST v1.1; 2. Secondary Objectives (1) To evaluate the overall survival (OS) of sacituzumab tirumotecan combined with pucotenlimab in advanced cholangiocarcinoma; (2) To assess progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), and time to response (TTR) in patients treated with sacituzumab tirumotecan combined with pucotenlimab, as determined by investigators based on RECIST v1.1; (3) To further evaluate PFS (as a standalone secondary endpoint); 3. Exploratory Objectives (1) To investigate the correlation between TROP2 expression, systemic immune biomarkers, and treatment efficacy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: TACSTD2 positive TROP2 protein
Patients with positive TROP2 protein
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: TROP2-targeted therapy
Previously received any of the following treatments (including in the context of adjuvant or neoadjuvant therapy): targeted TROP2 therapy
Cannot have received: topoisomerase I inhibitor
Any drug therapy containing targeted topoisomerase I, including antibody conjugated drug (ADC) therapy
Cannot have received: immune checkpoint inhibitor
Immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), immune cell therapy, and any other treatment targeting the tumor immune mechanism
Cannot have received: antibody-drug conjugate
Any drug therapy containing targeted topoisomerase I, including antibody conjugated drug (ADC) therapy
Cannot have received: TROP2-targeted antibody-drug conjugate
Previously received ADC targeting TROP2 or any drug treatment containing topoisomerase I inhibitors
Lab requirements
Blood counts
neutrophil count >= 1.2 × 10^9/L; platelet count >= 75 × 10^9/L; hemoglobin >= 9 g/dL
Kidney function
plasma Cr <= 1.5 ULN or creatinine clearance rate (Ccr) >= 60 ml/min
Liver function
AST, ALT, ALP <= 2.5 x ULN; TBIL <= 1.5 x ULN; if liver metastasis, ALT and AST <= 5 ULN
Having sufficient organ and bone marrow function ... Blood routine: neutrophil count (NEUT) >= 1.2 × 10^9/L; platelet count (PLT) >= 75 × 10^9/L; hemoglobin >= 9 g/dL; Liver function: AST, ALT, ALP <= 2.5 x ULN; TBIL <= 1.5 x ULN; If there is liver metastasis, ALT and AST should be <= 5ULN; Renal function: plasma Cr <= 1.5ULN or creatinine clearance rate (Ccr) >= 60 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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