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

NCT07105852 | Recruiting Phase 2

• 1 other identifier: SRRSH2025-0390
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 3.Exploratory Objectives (1) To investigate the correlation between TROP2 expression, systemic immune biomarkers, and treatment efficacy.

Conditions

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  2 year

Secondary Outcomes (4)

• Overall survival (OS)

  2 year

• Disease control rate (DCR)

  2year

• Progression-free survival (PFS)

  2 year

• Duration of response (DOR)

  2 year

Other Outcomes (2)

• The incidence, severity, and correlation with the investigational product of adverse events (all adverse events, treatment emergent adverse events, serious adverse event)

  2 year

• Biomarkers (TROP2 protein detection, CA-199, AFP, CEA)

  2 year

Study Arms (2)

First-line treatment cohort for advanced cholangiocarcinoma (Not treated before)

ACTIVE COMPARATOR

Intervention:Sacituzumab tirumotecan (iv)+Putolizumab injection (iv)

Drug: Sacituzumab tirumotecan (iv)+Putolizumab injection (iv)

Second-line treatment cohort for advanced cholangiocarcinoma (Treated before, but failed)

EXPERIMENTAL

Intervention:Sacituzumab tirumotecan (iv)+Putolizumab injection (iv)

Drug: Sacituzumab tirumotecan (iv)+Putolizumab injection (iv)

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.

First-line treatment cohort for advanced cholangiocarcinoma (Not treated before); Second-line treatment cohort for advanced cholangiocarcinoma (Treated before, but failed)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age \>= 18 years old; 2. Histologically confirmed unresectable or metastatic cholangiocarcinoma (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma)
• (1) First line treatment cohort:
• Patients who explicitly refuse chemotherapy;
• Patients who fail adjuvant therapy with chemotherapy;
• Patients who have not received systemic therapy; (2) Second line treatment cohort:
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• First line chemotherapy is effective, but toxicity is not tolerated;
• Disease progression after first-line chemotherapy regimen\]; 3. Patients with positive TROP2 protein; 4. The patient is a patient with distant metastasis or locally advanced stage who cannot undergo surgery or radiotherapy and has not received systemic treatment; 5. According to RECIST 1.1 tumor evaluation criteria, there is a measurable primary lesion; 6. No active autoimmune diseases; 7. No concurrent malignant tumors; 8. ECOG physical fitness score 0-1; 9. Expected survival period \>= 3 months; 10. Having sufficient organ and bone marrow function (not receiving blood transfusions, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first administration), defined as follows:
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• Blood routine: neutrophil count (NEUT) \>= 1.2 × 10\^9/L; platelet count (PLT) \>= 75 × 10\^9/L; hemoglobin \>= 9 g/dL;
• Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) \<= 2.5 x upper limit of normal (ULN); Total bilirubin (TBIL) \<= 1.5 × 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 (for males: GFR (ml/min)=(140 age) x body weight (kg) x 0.85/blood creatinine (mg/dl); For women: GFR (ml/min)=(140 age) x body weight (kg) x 0.85 x 0.85/blood creatinine (mg/dl);
• Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) \<= 1.5 × ULN; 11. For female subjects with fertility and male subjects with reproductive potential partners, they must agree to take effective medical contraceptive measures within 6 months from the signing of the informed consent form until the last administration; 12. Voluntarily join this study and sign an informed consent form. If the subject is unable to read and sign the informed consent form due to reasons such as lack of capacity, their guardian needs to act as a proxy for the informed process and sign the informed consent form. If the subject lacks the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (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

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Mingyu Chen

CONTACT

+86 187 5777 2223; mychen@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: July 3, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)