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

Phase 2

Recruiting

• Conditions: Metastatic Triple-negative Breast Cancer; Locally Advanced Triple-negative Breast Cancer
• Interventions: Drug: AK117; Drug: AK112; Drug: Nab paclitaxel; Drug: paclitaxel

• Registration Number: NCT05227664
• Lead Sponsor: Akeso

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-07
• Study Start: 2022-03-23
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-10
• Primary Completion: 2023-01-30
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)	AK117	Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)	AK112	Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)	Nab paclitaxel	Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)	AK117	Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)	Nab paclitaxel	Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)	AK112	Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)	Nab paclitaxel	Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)	paclitaxel	Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)	paclitaxel	Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)	paclitaxel	Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events (AEs)	Up to approximately 2 years	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.
Objective response rates (ORR)	Up to approximately 2 years	ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to approximately 2 years	PFS is defined as the time from the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Duration of response (DOR)	Up to approximately 2 years	DOR is defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first
Overall survival (OS)	Up to approximately 2 years	Overall survival is defined as the time from the start of treatment until death due to any cause.
Disease control rate (DCR)	Up to approximately 2 years	Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1
Time to response (TTR)	Up to approximately 2 years	TTR is defined for participants who had an objective response as the time from the start of treatment to the first occurrence of a documented unconfirmed response (CR or PR) .

Trial Locations

Locations (2)

Hunan Cancer Hospital; 🇨🇳 Changsha, China

Xiangyang Central Hospital; 🇨🇳 Xiangyang, China