- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05227664
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
September 8, 2022 updated by: Akeso
A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
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).
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Changsha, China
- Recruiting
- Hunan Cancer hospital
-
Contact:
- Quchang Ouyang, MD
-
Xiangyang, China
- Recruiting
- Xiangyang Central Hospital
-
Contact:
- Tienan Yi, PD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
|
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 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 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 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.
|
Experimental: cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
|
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
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 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.
|
Experimental: cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)
Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
|
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 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with adverse events (AEs)
Time Frame: 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.
|
Up to approximately 2 years
|
Objective response rates (ORR)
Time Frame: Up to approximately 2 years
|
ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1
|
Up to approximately 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: 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
|
Up to approximately 2 years
|
Time to response (TTR)
Time Frame: 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) .
|
Up to approximately 2 years
|
Progression-free survival (PFS)
Time Frame: 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).
|
Up to approximately 2 years
|
Overall survival (OS)
Time Frame: Up to approximately 2 years
|
Overall survival is defined as the time from the start of treatment until death due to any cause.
|
Up to approximately 2 years
|
Duration of response (DOR)
Time Frame: 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
|
Up to approximately 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 23, 2022
Primary Completion (Anticipated)
January 30, 2023
Study Completion (Anticipated)
October 30, 2023
Study Registration Dates
First Submitted
January 27, 2022
First Submitted That Met QC Criteria
January 27, 2022
First Posted (Actual)
February 7, 2022
Study Record Updates
Last Update Posted (Actual)
September 10, 2022
Last Update Submitted That Met QC Criteria
September 8, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Albumin-Bound Paclitaxel
Other Study ID Numbers
- AK117-203
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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