Clinical Trials Logo
  1. Home
  2. Triple Negative Breast Cancer
  3. NCT03251313

PD-1(Programmed Death-1) Antibody +GP as First Line Treatment for Triple Negative Breast Cancer(TNBC) Patients

Triple Negative Breast Cancer Clinical Trial

Official title:
Recombinant Humanized PD-1 Monoclonal Antibody (JS001) Combined With Gemcitabine and Cisplatin (GP) as First Line Treatment for Triple Negative Breast Cancer patients-a Phase 1 Clinical Trial

Clinical Trial Summary

This is a Phase I dose escalation trial to assess dose-limiting toxicity (DLT) and MTD of JS001+GP in advanced/metastatic TNBC patients, and to determine the recommended Phase II dose and the best combination regimen.

Clinical Trial Description

There will be 3 stages in this trial. Stage 1 is the dose escalation stage. JS001 will be tested in combination with GP in 3 dose levels. Level 1: 120mg Level 2: 240mg Level 3: 480mg Patients will receive JS001+GP for 6 cycles and JS001 maintenance therapy for up to approximately 2 years. JS001 will be given on d1 every 3 weeks with GP and every 2 weeks in maintenance therapy. The first group of participants will receive the lowest dose level of JS001 at 120mg. Each new group will receive a higher dose of JS001 than the group before it until 480mg. Stage 2 is the dose expansion stage. Dose expansion will be carried out to expand to 12 patients in the highest dose level at which the patient can tolerate well. This dose will also be recommended as phase 2 dose(RP2D). Stage 3 is the sequential treatment stage. Patients receive 6 cycles of GP without JS001 and then receive JS001 maintenance therapy for up to approximately 2 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03251313
Study type Interventional
Source Fudan University
Contact
Status Active, not recruiting
Phase Phase 1
Start date May 15, 2019
Completion date December 30, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05174832 - Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Withdrawn NCT03634150 - Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer Phase 1/Phase 2
Recruiting NCT03348098 - Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer Phase 2
Completed NCT04032080 - LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Recruiting NCT03165487 - Comparison of the Breast Tumor Microenvironment
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Recruiting NCT04452370 - Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Recruiting NCT04758780 - Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients Phase 2
Withdrawn NCT04268693 - Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Not yet recruiting NCT02685657 - Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer Phase 2
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT01276899 - Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
Completed NCT00998036 - Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors Phase 1
Recruiting NCT05309655 - Cardiac Outcomes With Near-Complete Estrogen Deprivation Early Phase 1
Active, not recruiting NCT03267316 - A First-in-Human Study of CAN04 in Patients With Solid Malignant Tumors Phase 1/Phase 2