Advanced triple-negative breast cancer
Conditions
Interventions
experimental group 1:GR1405 injection (10mg/kg) in combination with gemcitabine and cisplatin(GP)
experimental group 2:GR1405 injection (20mg/kg) in combination with gemcitabine and cisplatin(GP)
Sponsors
Harbin Medical University Cancer Hospital; The First Affiliated Hospital of Ustc Anhui Provincial Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or woman, aged 18 to 70 years; 2. Pathologically confirmed locally advanced or metastatic TNBC patients(If there is a metastatic focus, the histopathology of the metastatic focus shall prevail); 3. Locally advanced or metastatic TNBC patiens who cannot receive surgery have not previously received chemotherapy and/or targeted systemic therapy; or previously received neoadjuvant/adjuvant therapy (Anthracyclines and Paclitaxel should be included), The date of the last dose should be >=6 months after the confirmation of relapse; Radiotherapy for metastatic lesions is permitted, but patients are required to have ended radiotherapy for more than 4 weeks and have recovered from the effects of radiotherapy; 4. At least one measurable or evaluable lesion according to RECIST v1.1; 5. ECOG score is 1 point; 6. The patient or his legal representative signs a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Have experienced any NCI CTCAE v4.03 or greater than 3 grade irAE during previous immunotherapy treatment; 2. Have received any anti-PD-1 or anti-PD-L1 antibody treatment; 3. Abnormal organ or bone marrow function; 4. Have received other clinical trial medications within 4 weeks before randomizatiom; 5. Have received immunosuppressive drugs within 4 weeks before randomizatiom; 6. Have received or planning to receive a live and/or attenuated vaccine within 4 weeks before randomizatiom until 5 months after the last dose; 7. Have received or planning to receive major surgery within 4 weeks before randomizatiom or during the clinical trial; 8. Subjects with other malignant tumors previously or concurrently; 9. Female patients with pregnancy or lactation; 10. Women/men who have fertility refuse to adopt contraception during the trial period and within 5 months after the last dose; 11. Subjects with serious disease or complications, such as gastrointestinal bleeding, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, renal failure, glaucoma, uncontrolled diabetes and so on; 12. Within 3 months prior to screening, subjects with severe heart disease,for example: acute myocardial infarction, unstable angina pectoris, unstable arrhythmia or heart disease which is grade 2 or higer acoording to the New York Heart Association; 13. Subjects with central nervous system diseases (including brain metastases); 14. Subjects with uncontrollable hypercalcemia; or adjusted blood calcium> ULN or with clinically significant hypercalcemia requiring sustained treatment of bisphosphonates; 15. Subjects with a medical history of immunodeficiency; 16. Subjects with active hepatitis B or hepatitis C infection; 17. Severe infections treated with antibiotics within the first two weeks of randomization; 18. Subjects who have alcohol addiction (within one year) and/or drug abuse after asking; 19. Subjects with allergic constitution or allergic to known components of the drug; 20. Other subjects judged by the investigator to be ineligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR, PFS;Safety indicators: adverse events, vital signs, physical examinations, and laboratory tests;;Pharmacokinetic parameters: Cmax, Cmin, t1 / 2, AUC0-8, AUC0-t, AUCSS, Cav, CL, etc;;Immunogenicity indicators: anti-drug antibodies.; | — |
Countries
China
Contacts
Public ContactQuangang Zhu, Yangfeng Ding
Harbin Medical University Cancer Hospital
Outcome results
None listed