Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Breast Cancer (LABC) | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D-0502 | Drug | — | UNRESOLVED |
| JSKN016 Q2W | Drug | — | UNRESOLVED |
| JSKN016 Q3W | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- JSKN016 Q2W + D-0502
- interventionNames
- Drug: JSKN016 Q2W
- Drug: D-0502
- type
- EXPERIMENTAL
- label
- JSKN016 Q3W + D-0502
- interventionNames
- Drug: JSKN016 Q3W
- Drug: D-0502
Primary outcomes (3)
- measure
- Incidence of dose-limiting toxicities (DLTs)
- timeFrame
- From first dose through the end of Cycle 1 (approximately 21 days)
- measure
- Objective Response Rate (ORR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available