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

Sponsor
Sir Run Run Shaw Hospital
Study ID
NCT07105852
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab tirumotecan (iv)+Putolizumab injection (iv) — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 6, 2025
Start date
Jul 3, 2025
Status verified
Jul 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
59 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: First-line treatment cohort for advanced cholangiocarcinoma (Not treated before)
    Intervention:Sacituzumab tirumotecan (iv)+Putolizumab injection (iv)
  • Experimental: Second-line treatment cohort for advanced cholangiocarcinoma (Treated before, but failed)
    Intervention:Sacituzumab tirumotecan (iv)+Putolizumab injection (iv)

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 2 year ]

Central Contacts

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