NCT06767527

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P50-P75 for phase_3

Timeline
31mo left

Started Feb 2025

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2025Dec 2028

First Submitted

Initial submission to the registry

January 8, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2025

Completed
28 days until next milestone

Study Start

First participant enrolled

February 7, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

January 8, 2025

Last Update Submit

March 13, 2026

Conditions

Triple-Negative Breast Cancer (TNBC)

Outcome Measures

Primary Outcomes (2)

  • PFS assessed by IRRC

    Progression-Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC)

    Up to approximately 2 years

  • OS

    Overall survival (OS) is defined as the time from randomization to death due to any cause

    Up to approximately 4 years

Secondary Outcomes (8)

  • PFS assessed by investigator

    Up to approximately 2 years

  • ORR assessed by IRRC or investigators

    Up to approximately 2 years

  • DCR assessed by IRRC or investigators

    Up to approximately 2 years

  • DoR assessed by IRRC or investigators

    Up to approximately 2 years

  • TTR assessed by IRRC or investigators

    Up to approximately 2 years

  • +3 more secondary outcomes

Study Arms (2)

AK112

EXPERIMENTAL

AK112 Plus Nab-Paclitaxel

Drug: AK112Drug: Nab-paclitaxel

Placebo

PLACEBO COMPARATOR

Placebo Plus Nab-Paclitaxel

Drug: Nab-paclitaxelDrug: Placebo

Interventions

AK112DRUG

AK112 via intravenous (IV) infusion

AK112
Nab-paclitaxelDRUG

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

AK112Placebo
PlaceboDRUG

Placebo via IV infusion

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Xufang Yu

CONTACT

+86(0760)89873999clinicaltrials@akesobio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 10, 2025

Study Start

February 7, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-01

Locations

CN(1)