AK112 plus nab‑paclitaxel versus placebo plus nab‑paclitaxel for first‑line inoperable or metastatic triple‑negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double‑blind Phase 3 trial comparing AK112 combined with nab‑paclitaxel against placebo plus nab‑paclitaxel in patients with unresectable locally advanced or metastatic triple‑negative breast cancer who have not received prior systemic therapy for advanced disease. Participants must be 18–75 years old with ECOG performance status 0–1, at least one measurable lesion by RECIST v1.1, and adequate organ function. The study uses blinded assignment to active drug or placebo alongside standard chemotherapy and will monitor safety and anticancer efficacy outcomes. Treatment effect will be judged by tumor response and clinical outcomes while tracking adverse events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign a written informed consent form.
2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Histologically confirmed unresectable locally advanced or metastatic breast cancer with negative status for ER, PR, and HER-2.
6. Subjects who have not received prior systemic treatment for advanced breast cancer are eligible for the study.
7. Suitable for monotherapy with taxane-based agents.
8. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
9. Adequate organ function.

Exclusion Criteria:

1. Patients with locally recurrent disease who are eligible for surgery or radiotherapy.
2. History of other malignancies within the past 5 years.
3. Active autoimmune disease requiring systemic treatment within the past 2 years.
4. Pregnant or breastfeeding women.
5. 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.
6. Participants with clinically symptomatic pleural effusion, pericardial effusion, or ascites that require repeated drainage.
7. 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.
8. 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.

Where it's running

• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xufang Yu
• Email: clinicaltrials@akesobio.com
• Phone: +86(0760)89873999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.