Metastatic Breast CancerLocally Advanced Breast Cancer (LABC)
Investigational drug(s) / intervention(s)
JSKN016 Q2WJSKN016 Q3WD-0502
JSKN016 Q2W: 4 mg/kg, intravenous infusion, every 2 weeks
JSKN016 Q3W: 4 mg/kg, intravenous infusion, every 3 weeks
D-0502: 200 mg, oral, once daily
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Fudan University Shanghai Cancer center
Shanghai
China
More Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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