A Trial of SHR1258 in Patients With Biliary Tract Cancer

NCT04571710 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: HR-BLTN-II-BTC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response rate (ORR) evaluated by Blinded Independent Radiology Review Committee (BIRC) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

  up to 2 years

Secondary Outcomes (6)

• DOR

  up to 2 years

• DCR

  up to 2 years

• PFS

  up to 2 years

• OS

  up to 2 years

• AEs+SAEs

  from the first drug administration to within 28 days for the last SHR1258 dose

Study Arms (1)

Treatment group

EXPERIMENTAL

Intervention: Drug: SHR1258 400mg

Drug: SHR1258

Interventions

SHR1258 DRUG

Drug: SHR1258 400mg

Treatment group

Eligibility Criteria

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

You may qualify if:

• enrollment into the study:
• 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.
• Male or female, ≥18 years old.
• Histologically or cytologically confirmed (at a local laboratory) BTC
• 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.
• 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).
• 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.
• The laboratory test values must meet the functional level of important organs/systems meets
• ECOG-PS (see Appendix 2): 0 - 1.
• 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.
• 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.

You may not qualify if:

• 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.
• Male or female, ≥18 years old.
• Histologically or cytologically confirmed (at a local laboratory) BTC
• 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.
• 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).
• 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.
• The laboratory test values must meet the functional level of important organs/systems meets
• ECOG-PS (see Appendix 2): 0 - 1.
• 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.
• 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.
• Subjects presenting with any of the following will not be enrolled into the study:
• Prior receipt of HER2-targeted therapy.
• Concurrent anticancer therapy, other than the therapies being tested in this study.
• Radiation therapy administered within 2 weeks of first dose of study treatment.
• Laboratory values at screening outside the protocol-defined range.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: October 1, 2020
• Study Start: November 1, 2020
• Primary Completion: June 5, 2025
• Study Completion: June 5, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07