NCT07336771Not yet recruitingPhase 1/2
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
A Multicenter, Open-Label, Phase Ib/II Randomized Study of JSKN016 in Combination With D-0502 in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 13 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 23 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Diseases
- Metastatic breast cancer
- NCT number
- NCT07336771
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From 1 Jan 2026 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with ADCs containing topoisomerase I inhibitor payloads
Other illness
- Active interstitial lung disease or pneumonitis
- Uncontrolled cardiovascular disease or active infection
- Prior malignancy within 5 years (with specific exceptions)
Other
- Active or untreated CNS metastases
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.