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NCT Number: NCT05227664

A Study of AK117/AK112 in 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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Triple-negative Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Triple-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hunan Cancer Hospital, Changsha, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AK117

Drug

Intravenous (IV) infusion

AK112

Drug

Intravenous (IV) infusion

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.

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.

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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) .

  4. 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).

  5. 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.

Sponsors and collaborators

Lead sponsor

Akeso

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 7, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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