RecruitingPhase 2NCT07105852

Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma

Sponsor

Sir Run Run Shaw Hospital

Enrollment

59 participants

Start Date

Jul 3, 2025

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two cancer drugs — sacituzumab tirumotecan (an antibody-drug that targets cancer cells) and pucotenlimab (an immunotherapy drug) — in people with advanced bile duct cancer (cholangiocarcinoma) or gallbladder cancer. **You may be eligible if:** - You are 18 or older - You have been diagnosed with unresectable or metastatic cholangiocarcinoma or gallbladder cancer - Your tumor tests positive for a protein called TROP2 - You either refused chemotherapy, failed prior chemotherapy, or have not yet received systemic treatment (first-line cohort) - OR you had disease progress after first-line chemotherapy, or could not tolerate it (second-line cohort) - Your cancer cannot be removed by surgery or treated with radiation **You may NOT be eligible if:** - Your tumor does not express TROP2 - You have already received more than the allowed number of prior treatments - You have serious organ problems that would make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab tirumotecan (iv)+Putolizumab injection (iv)

When administering sacituzumab tirumotecan and putolizumab on the same day, the drugs should be given sequentially. Putolizumab is administered first. For the first co-administration, a 4-hour interval is required. If no severe infusion reactions or allergic reactions occur, subsequent administrations may proceed with a minimum interval of 60 minutes before administering sacituzumab tirumotecan. Putolizumab dosing: Dosage: 200 mg, intravenous (IV) infusion Dosing cycle: Every 3 weeks (administered on Day 1 of each cycle) Dose interruptions due to adverse events (AEs): Refer to the prescribing information. Sacituzumab tirumotecan dosing: Dosage: 4 mg/kg, intravenous (IV) infusion Dosing cycle: Every 2 weeks (administered on Day 1 of each cycle, with a permissible dosing window of 14 ± 3 days between doses) Dose interruptions due to adverse events (AEs): Refer to the prescribing information.

Locations(1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (Qingchun Campus) 3 Qingchun Road East, Shangcheng District, Hangzhou, Zhejiang, China

Hangzhou, Zhejiang, China

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NCT07105852