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

PHASE2RecruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

July 3, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2027

Conditions
Cholangiocarcinoma
Interventions
DRUG

Sacituzumab 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."

Trial Locations (1)

Unknown

RECRUITING

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

All Listed Sponsors
lead

Sir Run Run Shaw Hospital

OTHER

NCT07105852 - Exploring the Safety and Efficacy of Sacituzumab Tirumotecan Combined With Pucotenlimab in the Treatment of Advanced Cholangiocarcinoma | Biotech Hunter | Biotech Hunter