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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2028-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Triple-Negative Breast Cancer (TNBC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AK112

AK112 Plus Nab-Paclitaxel

Group Type EXPERIMENTAL

AK112

Intervention Type DRUG

AK112 via intravenous (IV) infusion

Nab-paclitaxel

Intervention Type DRUG

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

Placebo

Placebo Plus Nab-Paclitaxel

Group Type PLACEBO_COMPARATOR

Nab-paclitaxel

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo via IV infusion

Interventions

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AK112

AK112 via intravenous (IV) infusion

Intervention Type DRUG

Nab-paclitaxel

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

Intervention Type DRUG

Placebo

Placebo via IV infusion

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No