JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative … (NCT07336771) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
China60 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of dose-limiting toxicities (DLTs)
Timeframe: From first dose through the end of Cycle 1 (approximately 21 days)
2
Objective Response Rate (ORR)
Timeframe: From first dose through treatment discontinuation, assessed up to 12 months
3
Safety and tolerability (TEAEs, TRAEs, SAEs)
Timeframe: From first dose until 30 days after the last dose of study treatment.