A Phase II Study to Explore the Safety, Tolerability, and Preliminary Antitumor Activity of Sitravatinib and Tislelizumab in Patients With Locally Recurrent or Metastatic Triple Negative Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the efficacy and safety of tislelizumab in combination with sitavatinib in advanced triple-negative breast cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

Inclusion Criteria:

• Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments

• Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place)

• Histologically confirmed diagnosis of TNBC characterized by estrogen-receptor negative (ER-), progesterone receptor negative (PR-) and human epidermal growth factor-2 receptor negative (HER2-);

• ≤ 3 prior lines of systemic therapy

• For patients refractory/resistant to anti-PD-1/PD-L1 antibodies, there should be no anti-PD-1/PD-L1 treatment-related toxicity from prior therapies

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Adequate organ function

• Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drug(s), and have a negative serum pregnancy test ≤ 7 days of first dose of study drug(s)

• Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)

Exclusion Criteria:

• Active leptomeningeal disease or uncontrolled brain metastasis

• Active autoimmune diseases or history of autoimmune diseases that may relapse

• Any active malignancy ≤ 2 years

• Severe chronic or active infections (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drug(s)

• History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc

• Known history of human immunodeficiency virus (HIV) infection

• Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers

• Any major surgical procedure requiring general anesthesia ≤ 28 days before the first dose of study drug(s)

• Prior allogeneic stem cell transplantation or organ transplantation

• Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)

• Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring

• Any systemic chemotherapy within 28 days of the first dose of study drug(s) or hormone therapy, targeted therapy, or any investigational therapies Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)

• Inability to swallow capsules or disease significantly affecting gastrointestinal function

• Pregnant or breastfeeding woman NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.