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

NCT ID: NCT05227664

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2026-12-30

Brief 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 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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

AK117

Intervention Type: DRUG

Intravenous (IV) infusion

AK112

Intervention Type: DRUG

Intravenous (IV) infusion

Nab paclitaxel

Intervention Type: DRUG

Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

paclitaxel

Intervention Type: DRUG

Paclitaxel at a starting dose of 90 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)

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

Group Type: EXPERIMENTAL

AK117

Intervention Type: DRUG

Intravenous (IV) infusion

Nab paclitaxel

Intervention Type: DRUG

Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

paclitaxel

Intervention Type: DRUG

Paclitaxel at a starting dose of 90 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)

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

Group Type: EXPERIMENTAL

AK112

Intervention Type: DRUG

Intravenous (IV) infusion

Nab paclitaxel

Intervention Type: DRUG

Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

paclitaxel

Intervention Type: DRUG

Paclitaxel at a starting dose of 90 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Interventions

AK117

Intravenous (IV) infusion

Intervention Type: DRUG

AK112

Intravenous (IV) infusion

Intervention Type: DRUG

Nab paclitaxel

Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Intervention Type: DRUG

paclitaxel

Paclitaxel at a starting dose of 90 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akeso

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hunan Cancer Hospital

Changsha, , China

Site Status: RECRUITING

Xiangyang Central Hospital

Xiangyang, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xufang Yu, MD

Role: CONTACT

clincialtrails@akesobio.com

+86(0760)89873999

Facility Contacts

Quchang Ouyang, MD

Role: primary

Tienan Yi, PD

Role: primary

Other Identifiers

AK117-203

Identifier Type: -

Identifier Source: org_study_id