A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

Akeso

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Triple-negative Breast Cancer; Locally Advanced Triple-negative Breast Cancer

Treatments: Drug: AK117; Drug: Nab paclitaxel; Drug: paclitaxel; Drug: AK112

Study type: Interventional

Funder types: Industry

Identifiers

NCT05227664

AK117-203

Details and patient eligibility

About

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 chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 3 patient groups

cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)

Experimental group

Description:

Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.

Treatment:

Drug: AK112

Drug: paclitaxel

Drug: Nab paclitaxel

Drug: AK117

cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)

Experimental group

Description:

Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.

Treatment:

Drug: paclitaxel

Drug: Nab paclitaxel

Drug: AK117

cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)

Experimental group

Description:

Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.

Treatment:

Drug: AK112

Drug: paclitaxel

Drug: Nab paclitaxel