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New drug cocktail aims to shrink Hard-to-Treat breast tumors

NCT ID NCT05227664

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding two experimental drugs (AK117 and AK112) to standard chemotherapy can shrink tumors in people with advanced triple-negative breast cancer that hasn't been treated yet. About 120 participants will receive the combination. The main goals are to see how many respond and what side effects occur.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced triple-negative breast cancer Metastatic triple-negative breast cancer

Contacts and locations

Locations

  • Hunan Cancer Hospital

    Changsha, China

  • Xiangyang Central Hospital

    Xiangyang, China

More trials for these conditions

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