JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer

Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study ID
NCT07336771
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JSKN016 Q2W — DRUG
    4 mg/kg, intravenous infusion, every 2 weeks
  • JSKN016 Q3W — DRUG
    4 mg/kg, intravenous infusion, every 3 weeks
  • D-0502 — DRUG
    200 mg, oral, once daily

Study Details

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.

Key Dates

First listed
Jan 13, 2026
Start date
Jan 31, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JSKN016 Q2W + D-0502
  • Experimental: JSKN016 Q3W + D-0502

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) [ Time Frame: From first dose through the end of Cycle 1 (approximately 21 days) ]

Central Contacts

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