JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
NCT ID: NCT07336771
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2026-01-31
2028-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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JSKN016 Q2W + D-0502
JSKN016 Q2W
4 mg/kg, intravenous infusion, every 2 weeks
D-0502
200 mg, oral, once daily
JSKN016 Q3W + D-0502
JSKN016 Q3W
4 mg/kg, intravenous infusion, every 3 weeks
D-0502
200 mg, oral, once daily
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Jiangsu Alphamab Biopharmaceuticals Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JSKN016-204
Identifier Type: -
Identifier Source: org_study_id
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