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

NCT05227664 | Active Not Recruiting Phase 2

• 1 other identifier: AK117-203
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Objective response rates (ORR)

  ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1

  Up to approximately 2 years

• Number of participants with adverse events (AEs)

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.

  Up to approximately 2 years

Secondary Outcomes (5)

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of response (DOR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

• Progression-free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (3)

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

EXPERIMENTAL

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

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

cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)

EXPERIMENTAL

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

Drug: AK117; Drug: Nab paclitaxel; Drug: paclitaxel

cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)

EXPERIMENTAL

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

Drug: AK112; Drug: Nab paclitaxel; Drug: paclitaxel

Interventions

AK117 DRUG

Intravenous (IV) infusion

cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel); cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)

AK112 DRUG

Intravenous (IV) infusion

cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel); cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)

paclitaxel 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.

cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel); cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel); cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)

Nab paclitaxel 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.

cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel); cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel); cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Akeso: lead

Study Sites (2)

Hunan Cancer Hospital

Changsha, China

Location

Xiangyang Central Hospital

Xiangyang, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Taxes; Paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 7, 2022
• Study Start: March 23, 2022
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2025-03

Locations

CN (2)