Biliary Tract Cancer
Conditions
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
Interventions
DRUGSHR1258
Drug: SHR1258 400mg
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | up to 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| DCR | up to 2 years | Disease Control Rate |
| PFS | up to 2 years | Progression-Free-Survival |
| DOR | up to 2 years | Duration of response |
| AEs+SAEs | from the first drug administration to within 28 days for the last SHR1258 dose | Adverse event |
| Cmax | up to 2 years | Peak Plasma Concentration |
| OS | up to 2 years | overall survival |
Outcome results
None listed