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

NCT03251313 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-04-20

No results posted yet for this study

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.

Conditions

Interventions

COMBINATION_PRODUCT

JS001 120mg+GP

In this arm, JS001 120mg will be given at d1; Gem 1000mg/m2 d2,9; DDP(cisplatin) 75mg/m2 d2

COMBINATION_PRODUCT

JS001 240mg+GP

In this arm, JS001 240mg will be given at d1; Gem 1000mg/m2 d2,9; DDP 75mg/m2 d2

COMBINATION_PRODUCT

JS001 480mg+GP

In this arm, JS001 480mg will be given at d1; Gem 1000mg/m2 d2,9; DDP 75mg/m2 d2

COMBINATION_PRODUCT

GP followed by JS001

In this arm,Patients receive 6 cycles of GP without JS001 and then receive JS001 maintenance therapy for up to approximately 2 years. JS001 will be given at RP2D.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Xichun Hu, MD& PhD · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03251313 on ClinicalTrials.gov