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Metastatic Triple-negative Breast CancerPhase 2NCT05227664

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

A Phase 2 study testing AK117, AK112 and Nab paclitaxel in people with Metastatic Triple-negative Breast Cancer and Locally Advanced Triple-negative Breast Cancer, run by Akeso at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
AK117, AK112 and Nab paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesChina
Study dates
23 Mar 2022to 30 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Hunan Cancer Hospital

    Changsha

  • Xiangyang Central Hospital

    Xiangyang

Other trials in China

About this study

Official title: 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).

Being tested
AK117, AK112, Nab paclitaxel, paclitaxel
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK117Drug

    Intravenous (IV) infusion

  • AK112Drug

    Intravenous (IV) infusion

  • Nab paclitaxelDrug

    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.

  • paclitaxelDrug

    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.

Study groups in NCT05227664
Study groupRoleWhat they receive
cohort1(AK117 +AK112 +Nab-Paclitaxel/ Paclitaxel)ExperimentalSubjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Receives: Drug: AK117; Drug: AK112; Drug: Nab paclitaxel; Drug: paclitaxel
cohort2(AK117 +Nab-Paclitaxel/ Paclitaxel)ExperimentalSubjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Receives: Drug: AK117; Drug: Nab paclitaxel; Drug: paclitaxel
cohort3(AK112 +Nab-Paclitaxel/ Paclitaxel)ExperimentalSubjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.
Receives: Drug: AK112; Drug: Nab paclitaxel; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rates (ORR)

    ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1

    Measured: Up to approximately 2 years

  2. 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.

    Measured: Up to approximately 2 years

Secondary outcomes (5)

  1. 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

    Measured: Up to approximately 2 years

  2. 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

    Measured: Up to approximately 2 years

  3. 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) .

    Measured: Up to approximately 2 years

  4. 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).

    Measured: Up to approximately 2 years

  5. Overall survival (OS)

    Overall survival is defined as the time from the start of treatment until death due to any cause.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start23 Mar 2022
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227664
Sponsor's protocol ID
AK117-203
Status last verified
Mar 2025
First submitted
27 Jan 2022
Last updated
16 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Shao X, Tian C, Chen Z, Huang J, Wang Y, Sun T, Yi T, Wu Y, Sun W, Yu X, Wang ZM, Li B, Xia Y, Wang X, Ouyang Q. First-line PD-1/VEGF bispecific antibody plus chemotherapy in triple-negative breast cancer: a phase 2 trial. Nat Med. 2026 Aug 12. doi: 10.1038/s41591-026-04564-7. Online ahead of print.

    PubMed 42587052

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AK117, AK112 and Nab paclitaxel in people with Metastatic Triple-negative Breast Cancer and Locally Advanced Triple-negative Breast Cancer, run by Akeso at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rates (ORR) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05227664, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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