NCT06767527 AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer
| NCT ID | NCT06767527 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Akeso |
| Condition | Triple-Negative Breast Cancer (TNBC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 416 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 416 participants in total. It began in 2025-02-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06767527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Triple-Negative Breast Cancer (TNBC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06767527 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 416 participants.
Is NCT06767527 currently recruiting?
Yes, NCT06767527 is actively recruiting participants. Contact the research team at clinicaltrials@akesobio.com for enrollment information.
Where is the NCT06767527 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06767527 clinical trial?
NCT06767527 is sponsored by Akeso. The trial plans to enroll 416 participants.
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