Triple-Negative Breast Cancer (TNBC)Phase 3NCT06767527
AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
A Phase 3 study testing AK112 and Nab-paclitaxel in people with Triple-Negative Breast Cancer (TNBC), run by Akeso at 1 site in China.
Trial summary
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- AK112 and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to Dec 2028
- Phase
- Phase 3
- 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
- Voluntarily sign a written informed consent form.
- Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 3 months.
- Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
- Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
Show all 9Show fewer
- Suitable for monotherapy with taxane-based agents.
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Adequate organ function.
Who cannot join
- Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
- History of other malignancies within the past 5 years.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Pregnant or breastfeeding women.
- Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
- Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
- Participants with a history of immune deficiency; those who test positive for HIV antibodies; those currently using systemic corticosteroids or other immunosuppressive agents on a long-term basis.
- Individuals with known active tuberculosis (TB), or those suspected of having active TB (who must undergo clinical evaluation for exclusion), and those with known active syphilis infection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Binghe Xu, 010-87788993, xubinghe@medmail.com.cn
About this study
Official title: A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- AK112, Nab-paclitaxel, Placebo
- 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.
AK112Drug
AK112 via intravenous (IV) infusion
Nab-paclitaxelDrug
Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle
PlaceboDrug
Placebo via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| AK112 | Experimental | AK112 Plus Nab-Paclitaxel Receives: Drug: AK112; Drug: Nab-paclitaxel |
| Placebo | Placebo comparator | Placebo Plus Nab-Paclitaxel Receives: Drug: Nab-paclitaxel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS assessed by IRRC
Progression-Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC)
Measured: Up to approximately 2 years
OS
Overall survival (OS) is defined as the time from randomization to death due to any cause
Measured: Up to approximately 4 years
Secondary outcomes (8)
PFS assessed by investigator
Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
ORR assessed by IRRC or investigators
Objective Response Rate (ORR) is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by IRRC or investigators based on RECIST 1.1 is presented.
Measured: Up to approximately 2 years
DCR assessed by IRRC or investigators
Disease control rate (DCR) is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by IRRC or investigators using RECIST v1.1
Measured: Up to approximately 2 years
DoR assessed by IRRC or investigators
Duration of response (DoR) is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
TTR assessed by IRRC or investigators
Time to response (TTR) is defined as the time to response based on RECIST v1.1.
Measured: Up to approximately 2 years
Adverse Events (AEs)
Incidence and severity of participants with adverse events
Measured: Up to approximately 2 years
Cmax and Cmin
AK112 serum drug concentrations in subjects at different time points after AK112 administration.
Measured: Up to approximately 2 years
Anti-drug antibodies (ADA)
Number of subjects with detectable anti-drug antibodies (ADA).
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.
- First posted10 Jan 2025
- Study start7 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by AkesoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akeso
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767527
- Sponsor's protocol ID
- AK112-308
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Plus Nab-paclitaxel Versus Placebo Plus Nab-paclitaxel as First-line Treatment for Locally Advanced Unresectable or Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06767527
- Acronym / sponsor ID
- AK112-308
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- AkesoIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind study aims to assess the safety and efficacy of AK112 in combination with Nab-Paclitaxel, compared to a placebo plus Nab-Paclitaxel, as a first-line treatment for inoperable locally advanced or metastatic triple-negative breast cancer (TNBC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK112 | Experimental | Drug: AK112, Drug: Nab-paclitaxelAK112 Plus Nab-Paclitaxel |
| Placebo | Placebo comparator | Drug: Nab-paclitaxel, Drug: PlaceboPlacebo Plus Nab-Paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily sign a written informed consent form.
- Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy of ≥ 3 months.
- Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
Key exclusion criteria (8 listed)
- Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
- History of other malignancies within the past 5 years.
- Active autoimmune disease requiring systemic treatment within the past 2 years.
- Pregnant or breastfeeding women.
- Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK112AK112 via intravenous (IV) infusion | Drug | AK112 |
| Nab-paclitaxelNab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle | Drug | AK112, Placebo |
| PlaceboPlacebo via IV infusion | Drug | Placebo |
Primary outcome
PFS assessed by IRRC
Time frame: Up to approximately 2 years
Progression-Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC)
OS
Time frame: Up to approximately 4 years
Overall survival (OS) is defined as the time from randomization to death due to any cause
8 secondary outcomes
PFS assessed by investigator
Time frame: Up to approximately 2 years
ORR assessed by IRRC or investigators
Time frame: Up to approximately 2 years
DCR assessed by IRRC or investigators
Time frame: Up to approximately 2 years
DoR assessed by IRRC or investigators
Time frame: Up to approximately 2 years
TTR assessed by IRRC or investigators
Time frame: Up to approximately 2 years
Adverse Events (AEs)
Time frame: Up to approximately 2 years
Cmax and Cmin
Time frame: Up to approximately 2 years
Anti-drug antibodies (ADA)
Time frame: Up to approximately 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
Related trials for Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
Triple-Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK112 and Nab-paclitaxel in people with Triple-Negative Breast Cancer (TNBC), run by Akeso at 1 site 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 9 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: looking for participants now, 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 1 site 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Xufang Yu (+86(0760)89873999, clinicaltrials@akesobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS assessed by IRRC (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?
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.