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A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.

NCT07729033 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-07-27

No results posted yet for this study

Summary

This is a prospective, single-arm, Phase II study evaluating sacituzumab tirumotecan combined with envafolimab in patients with TROP2-positive advanced biliary tract cancers who have progressed on first-line immunochemotherapy. Up to 28 eligible patients will be enrolled.After screening, eligible patients receive sacituzumab tirumotecan (5 mg/kg IV, d1, Q2W) plus envafolimab (300 mg SC, d1, Q2W) for 3 cycles, with subsequent treatment at the investigator's discretion.

Tumor imaging assessments per RECIST v1.1 are performed at Week 6, then every 6 weeks (up to 48 weeks) and every 12 weeks (thereafter) until disease progression, new therapy, loss to follow-up, or death. Post-treatment survival follow-up is conducted by phone every 3 months.

The study includes a safety run-in (6 patients) followed by an expansion phase using Simon's two-stage design (first stage: 15 patients; second stage: total 28 patients). The safety run-in stops if \>2 DLTs occur; expansion proceeds if ≤2 DLTs. The trial is terminated if ≤1 objective response is observed in the first 15 expansion patients.

The primary endpoint is ORR(investigator-assessed per RECIST v1.1). Secondary endpoints include OS, PFS, DCR, DOR, safety, and tolerability.

Conditions

  • Advanced Biliary Tract Cancers

Interventions

DRUG

Sacituzumab tirumotecan combined with envafolimab

Sacituzumab tirumotecan 5 mg/kg, administered intravenously (IV) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Envafolimab 300 mg, administered subcutaneously (SC) on Day 1 of each cycle (d1), Q2W, for 3 cycles. Subsequent treatment decisions will be made by the investigator based on comprehensive efficacy assessments.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2028-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729033 on ClinicalTrials.gov