Locally Advanced Breast Cancer (LABC), Metastatic Breast Cancer
Conditions
Brief summary
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective estrogen receptor degrader (SERD) D-0502 in patients with locally advanced or metastatic hormone receptor-positive (HR+), HER2-negative breast cancer who have previously progressed on CDK4/6 inhibitor-based endocrine therapy. Approximately 60 patients will be randomized in a 1:1 ratio to receive JSKN016 administered intravenously every 2 weeks (Q2W) or every 3 weeks (Q3W), in combination with daily oral D-0502. Each dosing cohort will include a safety lead-in phase to assess DLTs prior to cohort expansion. Tumor response will be assessed according to RECIST v1.1.
Interventions
DRUGJSKN016 Q2W
4 mg/kg, intravenous infusion, every 2 weeks
DRUGJSKN016 Q3W
4 mg/kg, intravenous infusion, every 3 weeks
DRUGD-0502
200 mg, oral, once daily
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Histologically or cytologically confirmed locally advanced or metastatic HR-positive, HER2-negative breast cancer * HR-positive defined as ER and/or PR ≥1% by IHC * HER2-negative per ASCO/CAP guidelines * At least one measurable extracranial lesion per RECIST v1.1 * ECOG performance status 0-1 * Prior progression on CDK4/6 inhibitor plus endocrine therapy * Adequate organ and cardiac function * Postmenopausal women, or premenopausal women receiving ovarian function suppression
Exclusion criteria
* Active or untreated CNS metastases * Prior treatment with ADCs containing topoisomerase I inhibitor payloads * Active interstitial lung disease or pneumonitis * Uncontrolled cardiovascular disease or active infection * Prior malignancy within 5 years (with specific exceptions) * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicities (DLTs) | From first dose through the end of Cycle 1 (approximately 21 days) |
| Objective Response Rate (ORR) | From first dose through treatment discontinuation, assessed up to 12 months |
| Safety and tolerability (TEAEs, TRAEs, SAEs) | From first dose until 30 days after the last dose of study treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) | From first dose until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months |
| Disease Control Rate (DCR) | From first dose through 24 weeks |
| Overall Survival (OS) | From first dose until death from any cause, assessed up to 36 months |
| Duration of Response (DoR) | From first documented objective response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months |
| Clinical Benefit Rate (CBR) | From first dose through 24 weeks |
Countries
China
Contacts
Primary ContactXiaowen Tang
Outcome results
None listed