Back to resultsA Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
Primary Purpose
Metastatic Triple-negative Breast Cancer, Locally Advanced Triple-negative Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
AK117
AK112
Nab paclitaxel
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Triple-negative Breast Cancer
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
Sites / Locations
- Hunan Cancer HospitalRecruiting
- Xiangyang Central HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)
Arm Description
Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Objective response rates (ORR)
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
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.
Secondary Outcome Measures
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
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
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) .
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).
Overall survival (OS)
Overall survival is defined as the time from the start of treatment until death due to any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05227664
Brief Title
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
Official Title
A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akeso
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Triple-negative Breast Cancer, Locally Advanced Triple-negative Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
Arm Type
Experimental
Arm Description
Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Arm Title
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)
Arm Type
Experimental
Arm Description
Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Arm Title
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)
Arm Type
Experimental
Arm Description
Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
AK117
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
AK112
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Intervention Description
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
Intervention Name(s)
paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective response rates (ORR)
Description
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
Time Frame
Up to approximately 2 years
Title
Number of participants with adverse events (AEs)
Description
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.
Time Frame
Up to approximately 2 years
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1
Time Frame
Up to approximately 2 years
Title
Duration of response (DOR)
Description
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
Time Frame
Up to approximately 2 years
Title
Time to response (TTR)
Description
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) .
Time Frame
Up to approximately 2 years
Title
Progression-free survival (PFS)
Description
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).
Time Frame
Up to approximately 2 years
Title
Overall survival (OS)
Description
Overall survival is defined as the time from the start of treatment until death due to any cause.
Time Frame
Up to approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weifeng Song, MD
Phone
+86(0760)89873999
Email
clincialtrails@akesobio.com
Facility Information:
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quchang Ouyang, MD
Facility Name
Xiangyang Central Hospital
City
Xiangyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tienan Yi, PD
12. IPD Sharing Statement
Learn more about this trial
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
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