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A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib Plus Tislelizumab or Combination With Nab-paclitaxel in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer (TNBC)

NCT04734262 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-11-18

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of sitravatinib plus tislelizumab or combination with nab-paclitaxel in locally recurrent or metastatic triple-negative breast cancer (TNBC) patients.

Conditions

Interventions

DRUG

Sitravatinib

Sitravatinib QD PO Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

DRUG

Tislelizumab

Tislelizumab Q3W IV Tislelizumab is a programmed death receptor-1 (PD-1) blocking antibody

DRUG

Nab-paclitaxel

Nab-paclitaxel D1, D8 Q3W IV Nab-paclitaxel is a chemotherapy drug which combines the chemotherapy drug paclitaxel with albumin

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhimin Shao, MD, PhD · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT04734262 on ClinicalTrials.gov