Health TrialsbyHealthPanel

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

ConditionTriple-Negative Breast Cancer (TNBC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AK112

    Drug

    AK112 via intravenous (IV) infusion

  • Nab-paclitaxel

    Drug

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

  • Placebo

    Drug

    Placebo via IV infusion

Treatment groups

416 Participants
are divided into 2 treatment groups
Group A: AK112Experimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

PFS assessed by IRRC

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

Time frame
Up to approximately 2 years
2

OS

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

Time frame
Up to approximately 4 years

Secondary outcomes

1

PFS assessed by investigator

Progression-free survival is defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by investigator or death due to any cause, whichever occurs first.

Time frame
Up to approximately 2 years
2

ORR assessed by IRRC or investigators

Objective Response Rate (ORR) is defined as the percentage of participants in the analysis population who have a complete response (CR: disappearance of all lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experienced a CR or PR as assessed by IRRC or investigators based on RECIST 1.1 is presented.

Time frame
Up to approximately 2 years
3

DCR assessed by IRRC or investigators

Disease control rate (DCR) is defined as the sum rate of CR, PR and Stable Disease (SD), as determined by IRRC or investigators using RECIST v1.1

Time frame
Up to approximately 2 years
4

DoR assessed by IRRC or investigators

Duration of response (DoR) is defined as the time period from the date of initial CR or PR until the date of PD or death due to any cause, whichever occurs first.

Time frame
Up to approximately 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
Apply now