A Phase II Study of AK117/AK112 in Combination With Chemotherpy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherpy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

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

Details

• Lead Sponsor: Akeso
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression

• No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC

• Eligible for taxane monotherapy

• A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 5 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity.

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Measurable disease as defined by RECIST v1.1

• Adequate hematologic and end-organ function

Exclusion Criteria:

• Known central nervous system (CNS) disease, except for asymptomatic CNS metastases

• Leptomeningeal disease

• Pregnancy or lactation

• History of autoimmune disease

• Prior allogeneic stem cell or solid organ transplantation

• Positive test for human immunodeficiency virus

• Active hepatitis B or hepatitis C

• Receipt of a live, attenuated vaccine within 30 days prior to randomization, during treatment