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

Akeso

Status and phase: Not yet enrolling; Phase 3

Conditions: Triple-Negative Breast Cancer (TNBC)

Treatments: Drug: Placebo; Drug: Nab-paclitaxel; Drug: AK112

Study type: Interventional

Funder types: Industry

Identifiers

NCT06767527

AK112-308

Details and patient eligibility

About

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).

Enrollment: 416 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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416 participants in 2 patient groups, including a placebo group

AK112

Experimental group

Description:

AK112 Plus Nab-Paclitaxel

Treatment:

Drug: Nab-paclitaxel

Drug: AK112

Placebo

Placebo Comparator group

Description:

Placebo Plus Nab-Paclitaxel

Treatment:

Drug: Nab-paclitaxel

Drug: Placebo