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Not yet recruiting NCT07336771

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

Phase I / Phase II Interventional Metastatic Breast Cancer Locally Advanced Breast Cancer (LABC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JSKN016 Q2W, JSKN016 Q3W, D-0502.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence of dose-limiting toxicities (DLTs) [Time frame: From first dose through the end of Cycle 1 (approximately 21 days)]
  • Objective Response Rate (ORR) [Time frame: From first dose through treatment discontinuation, assessed up to 12 months]
  • Safety and tolerability (TEAEs, TRAEs, SAEs) [Time frame: From first dose until 30 days after the last dose of study treatment.]
Secondary outcome measures (5)
  • Disease Control Rate (DCR) [Time frame: From first dose through 24 weeks]
  • Duration of Response (DoR) [Time frame: From first documented objective response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months]
  • Clinical Benefit Rate (CBR) [Time frame: From first dose through 24 weeks]
  • Progression-Free Survival (PFS) [Time frame: From first dose until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 24 months]
  • Overall Survival (OS) [Time frame: From first dose until death from any cause, assessed up to 36 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer center — Shanghai

Identifiers

NCT: NCT07336771 · JSKN016-204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗