A Study of SHR-A1904 in Previous Systemic Treatment Failed Biliary Tract Cancer

Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study ID
NCT07450976
Phase
PHASE2
Status
Recruiting
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Conditions

  • Biliary Tract Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SHR-A1904 for Injection — DRUG
    SHR-A1904 for injection, different doses.

Study Details

This is a multicenter, Phase 2 clinical trial to evaluate the efficacy and safety, PK and immunogenicity of SHR-A1904 in patients with advanced or metastatic biliary tract cancer (BTC). Patients will treat with SHR-A1904 until unacceptable toxicity or disease progression.

Key Dates

First listed
Mar 5, 2026
Start date
Mar 25, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
151 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SHR-A1904 Cohort A Group
    SHR-A1904 for injection, low dose.
  • Experimental: SHR-A1904 Cohort B Group
    SHR-A1904 for injection, high dose.

Primary Outcome Measure

Objective response rate (ORR) assessed by investigator. [ Time Frame: Until progression, assessed up to approximately 1 year. ]

Central Contacts

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