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OncoMatch/Clinical Trials/NCT07450976

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

Is NCT07450976 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies SHR-A1904 for for biliary tract cancer.

Phase 2RecruitingSuzhou Suncadia Biopharmaceuticals Co., Ltd.NCT07450976Data as of Jun 2026Location: China

Treatment: SHR-A1904 forThis 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.

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Extracted eligibility criteria

Treatments studied

Other

SHR-A1904 for

Cancer type

Cholangiocarcinoma

Biomarker criteria

Required: CLDN18 positive expression

CLDN18.2 positive expression

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

Min 1 prior line

Must have received: systemic chemotherapy

Subjects who failed or intolerance after systemic chemotherapies

Cannot have received: anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy, biotherapy, or other clinical research drugs)

Received anti-tumor treatment such as chemotherapy, radiotherapy, immunotherapy, biotherapy or other clinical research drugs within 4 weeks before the first administration

Lab requirements

Liver function

Child-Pugh liver function grade C excluded

Cardiac function

Severe heart disease within 6 months before first administration excluded

The main organ function is normal, in line with the program requirements; Child-Pugh liver function grade C excluded; severe heart disease within 6 months before first administration excluded

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07450976 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy, biotherapy, or other clinical research drugs) disqualifies patients from enrollment.

Does this trial require CLDN18?

Yes, CLDN18 positive expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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