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NCT Number: NCT07336771

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

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Locally Advanced Breast Cancer (LABC) Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JSKN016 Q2W

Drug

4 mg/kg, intravenous infusion, every 2 weeks

JSKN016 Q3W

Drug

4 mg/kg, intravenous infusion, every 3 weeks

D-0502

Drug

200 mg, oral, once daily

Primary outcomes

  1. Incidence of dose-limiting toxicities (DLTs)

    Time frame: From first dose through the end of Cycle 1 (approximately 21 days)

  2. Objective Response Rate (ORR)

    Time frame: From first dose through treatment discontinuation, assessed up to 12 months

  3. Safety and tolerability (TEAEs, TRAEs, SAEs)

    Time frame: From first dose until 30 days after the last dose of study treatment.

Secondary outcomes

  1. Disease Control Rate (DCR)

    Time frame: From first dose through 24 weeks

  2. 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

  3. Clinical Benefit Rate (CBR)

    Time frame: From first dose through 24 weeks

  4. 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

  5. Overall Survival (OS)

    Time frame: From first dose until death from any cause, assessed up to 36 months

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaowen Tang

CONTACT

[email protected]

+86-512-62850800

Sponsors and collaborators

Lead sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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