Clinical Trial: NCT05227664
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Akeso |
| Information Provided By: | Akeso |
| Last Update Posted: | 2026-03-16 |
Study Overview
Brief Summary
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
Official Title
A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Conditions
Metastatic Triple-negative Breast Cancer, Locally Advanced Triple-negative Breast Cancer
Intervention / Treatment
- Drug: AK117
- Drug: AK112
- Drug: Nab paclitaxel
- Drug: paclitaxel
Other Study ID Numbers
- AK117-203
Start Date (Actual)
2022-03-23
Primary Completion Date (Estimated)
2026-12-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
120
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Akeso |
| Information Provided By: | Akeso |
| Last Update Posted: | 2026-03-16 |
Study Overview
Brief Summary
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
Official Title
A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer
Conditions
Metastatic Triple-negative Breast Cancer, Locally Advanced Triple-negative Breast Cancer
Intervention / Treatment
- Drug: AK117
- Drug: AK112
- Drug: Nab paclitaxel
- Drug: paclitaxel
Other Study ID Numbers
- AK117-203
Start Date (Actual)
2022-03-23
Primary Completion Date (Estimated)
2026-12-30
Study Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
120
Study Type
Interventional
Phase
Phase 2