A Trial of SHR1258 in Patients With Biliary Tract Cancer

NCT ID: NCT04571710

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2025-06-05

Brief Summary

The study is being conducted to evaluate the efficacy and safety of SHR1258 in subjects with advanced/ metastatic HER2-altered biliary tract cancers

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Intervention: Drug: SHR1258 400mg

Group Type: EXPERIMENTAL

SHR1258

Intervention Type: DRUG

Drug: SHR1258 400mg

Interventions

SHR1258

Drug: SHR1258 400mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• enrollment into the study:

1. Signed and dated written informed consent which is approved by Institutional Review Board (IRB)/Ethics Committee (EC), willing and able to comply with scheduled treatment, all examinations at study visits, and other study procedures.

2. Male or female, ≥18 years old.

3. Histologically or cytologically confirmed (at a local laboratory) BTC

4. Received up to two prior regimen of systemic therapy for advanced disease, including 1 gemcitabine-containing regimen, and experienced disease progression after or developed intolerance to the most recent prior therapy.

5. Sufficient tumor tissue samples (archival or fresh biopsy samples) will be provided by all subjects prior to the administration of pyrotinib (for retrospective confirmation of HER2 alteration through a central laboratory if applicable).

6. Must have measureable disease per RECIST v1.1. The definition of CT or MRI measurable lesion as the target lesion: according to RECIST v1.1, the long diameter of such lesion should be ≥ 10 mm by the CT scan or the short diameter of enlarged lymph nodes ≥ 15 mm.

7. The laboratory test values must meet the functional level of important organs/systems meets

8. ECOG-PS (see Appendix 2): 0 - 1.

9. If subjects have active hepatitis B virus (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be < 500 IU/mL and are willing to receive antiviral therapy throughout the study; subjects with positive hepatitis C (HCV) ribonucleic acid (RNA) must receive antiviral therapy in accordance with the local standard treatment guideline and have ≤ CTCAE Grade 1 elevated hepatic function.

10. Women of childbearing potential (WOCBP) must have a serum pregnancy test within 7 days before the first dose and the result is negative. WOCBP and male subjects whose partners are WOCBP must agree to use effective contraception method during the study period and within 8 weeks after the last dose of study medication.

1. Signed and dated written informed consent which is approved by Institutional Review Board (IRB)/Ethics Committee (EC), willing and able to comply with scheduled treatment, all examinations at study visits, and other study procedures.

2. Male or female, ≥18 years old.

3. Histologically or cytologically confirmed (at a local laboratory) BTC

4. Received up to two prior regimen of systemic therapy for advanced disease, including 1 gemcitabine-containing regimen, and experienced disease progression after or developed intolerance to the most recent prior therapy.

5. Sufficient tumor tissue samples (archival or fresh biopsy samples) will be provided by all subjects prior to the administration of pyrotinib (for retrospective confirmation of HER2 alteration through a central laboratory if applicable).

6. Must have measureable disease per RECIST v1.1. The definition of CT or MRI measurable lesion as the target lesion: according to RECIST v1.1, the long diameter of such lesion should be ≥ 10 mm by the CT scan or the short diameter of enlarged lymph nodes ≥ 15 mm.

7. The laboratory test values must meet the functional level of important organs/systems meets

8. ECOG-PS (see Appendix 2): 0 - 1.

9. If subjects have active hepatitis B virus (HBV) infection: HBV- deoxyribonucleic acid (DNA) must be < 500 IU/mL and are willing to receive antiviral therapy throughout the study; subjects with positive hepatitis C (HCV) ribonucleic acid (RNA) must receive antiviral therapy in accordance with the local standard treatment guideline and have ≤ CTCAE Grade 1 elevated hepatic function.

10. Women of childbearing potential (WOCBP) must have a serum pregnancy test within 7 days before the first dose and the result is negative. WOCBP and male subjects whose partners are WOCBP must agree to use effective contraception method during the study period and within 8 weeks after the last dose of study medication.

Exclusion Criteria

Subjects presenting with any of the following will not be enrolled into the study:

1. Prior receipt of HER2-targeted therapy.

2. Concurrent anticancer therapy, other than the therapies being tested in this study.

3. Radiation therapy administered within 2 weeks of first dose of study treatment.

4. Laboratory values at screening outside the protocol-defined range.

5. Clinically significant or uncontrolled cardiac disease.

1) Malignant tumors with other pathological types, such as mixed cancer, double primary cancers.

2) Medical history of other active malignancies within last 5 years. 3) Subjects with active central nervous system (CNS) metastases are excluded. Subjects with history or evidence of current leptomeningeal metastases are excluded.

1. Severe cardiac disease

2. Prior to the first dose of study treatment, patients with the following conditions: inability to swallow, chronic diarrhea, intestinal obstruction, gastrointestinal perforation or gastrectomy, colitis or other diseases or special conditions that affect drug administration and absorption.

3. Prior to the first dose of study treatment, patients with severe effusions with clinical symptoms

4. Symptoms of severe infection or evidence for microbiological/viral diagnosis.

5. Congenital or acquired immunodeficiency (e.g., human immunodeficiency virus [HIV] infection).

1. Within 2 weeks prior to the first dose of study treatment, or during the study period, patients receive or are anticipated to receive continuous strong CYP3A4 inducers or inhibitors, P-gp inhibitors.

11. Others:

1. Per investigator's judgment, other diseases or laboratory evidence that would cause serious threats to the safety of the patients, or which are not in the best interest of the patient to participate in the study are excluded

2. Per investigator's judgment, other situations that may confuse the study results or would affect the subjects' ability to comply with study procedures are excluded, such as alcoholism, drug abuse, criminal detention, etc.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HR-BLTN-II-BTC

Identifier Type: -

Identifier Source: org_study_id