ClinicalTrialsFinder
RecruitingPhase 3NCT06767527

AK112 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/ Metastatic Triple-negative Breast Cancer

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

Sponsor

Akeso

Enrollment

416 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria9

  • 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.
  • 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.

Exclusion Criteria8

  • 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.

Interventions

DRUGAK112

AK112 via intravenous (IV) infusion

DRUGNab-paclitaxel

Nab-Paclitaxel 100mg/m2 via IV infusion on Days 1, 8, and 15 of each 28-day cycle

DRUGPlacebo

Placebo via IV infusion

Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06767527