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A Trial of SHR1258 in Patients With Biliary Tract Cancer

Primary Purpose

Biliary Tract Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR1258
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

  • Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for 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.

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.
  6. Target disease exclusion criteria:

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.

4) By the date of first dose of study treatment, the washout period of previous drug treatment / medical intervention does not meet the following requirements 7. Medical history exclusion criteria:

  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).

8. History of allergy to the study drugs or components. 9. Pregnancy or breastfeeding. 10. Concomitant treatments exclusion criteria:

  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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment group

    Arm Description

    Intervention: Drug: SHR1258 400mg

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    DOR
    Duration of response
    DCR
    Disease Control Rate
    PFS
    Progression-Free-Survival
    OS
    overall survival
    AEs+SAEs
    Adverse event
    Cmax
    Peak Plasma Concentration

    Full Information

    First Posted
    September 17, 2020
    Last Updated
    September 27, 2020
    Sponsor
    Jiangsu HengRui Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04571710
    Brief Title
    A Trial of SHR1258 in Patients With Biliary Tract Cancer
    Official Title
    A Phase 2 Study of Pyrotinib in Patients With Advanced/ Metastatic HER2-Altered Biliary Tract Cancers Who Have Failed One or Two Prior Lines of Therapies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    May 1, 2022 (Anticipated)
    Study Completion Date
    August 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu HengRui Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Tract Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    Intervention: Drug: SHR1258 400mg
    Intervention Type
    Drug
    Intervention Name(s)
    SHR1258
    Intervention Description
    Drug: SHR1258 400mg
    Primary Outcome Measure Information:
    Title
    Objective response rate
    Description
    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).
    Time Frame
    up to 2 years
    Secondary Outcome Measure Information:
    Title
    DOR
    Description
    Duration of response
    Time Frame
    up to 2 years
    Title
    DCR
    Description
    Disease Control Rate
    Time Frame
    up to 2 years
    Title
    PFS
    Description
    Progression-Free-Survival
    Time Frame
    up to 2 years
    Title
    OS
    Description
    overall survival
    Time Frame
    up to 2 years
    Title
    AEs+SAEs
    Description
    Adverse event
    Time Frame
    from the first drug administration to within 28 days for the last SHR1258 dose
    Title
    Cmax
    Description
    Peak Plasma Concentration
    Time Frame
    up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for 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. Exclusion Criteria: 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. Clinically significant or uncontrolled cardiac disease. Target disease exclusion criteria: 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. 4) By the date of first dose of study treatment, the washout period of previous drug treatment / medical intervention does not meet the following requirements 7. Medical history exclusion criteria: Severe cardiac disease 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. Prior to the first dose of study treatment, patients with severe effusions with clinical symptoms Symptoms of severe infection or evidence for microbiological/viral diagnosis. Congenital or acquired immunodeficiency (e.g., human immunodeficiency virus [HIV] infection). 8. History of allergy to the study drugs or components. 9. Pregnancy or breastfeeding. 10. Concomitant treatments exclusion criteria: 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: 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 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.

    12. IPD Sharing Statement

    Learn more about this trial

    A Trial of SHR1258 in Patients With Biliary Tract Cancer

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