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

Metastatic Triple-negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05227664
• Other study ID #: AK117-203
• Status: Recruiting
• Phase: Phase 2
• Start date: March 23, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2022
• Source: Akeso
• Contact: Weifeng Song, MD
• Phone: +86(0760)89873999
• Email: clincialtrails[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Triple-negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• AK117
AK117 at a dose of 45mg/kg via intravenous (IV) infusion on Days 1,8 ,15 and 22of each 28-day cycle until disease progression or unacceptable toxicity
• AK112
AK112 at a dose of 20mg/kg via intravenous (IV) infusion on Days 1and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
• 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.
• 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.

Locations

Country	Name	City	State
China	Hunan Cancer Hospital	Changsha
China	Xiangyang Central Hospital	Xiangyang

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Disease control rate (DCR)	Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1	Up to approximately 2 years
Secondary	Duration of response (DOR)	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	Up to approximately 2 years
Secondary	Time to response (TTR)	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) .	Up to approximately 2 years
Secondary	Progression-free survival (PFS)	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).	Up to approximately 2 years
Secondary	Overall survival (OS)	Overall survival is defined as the time from the start of treatment until death due to any cause.	Up to approximately 2 years