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Clinical Trials in China / NCT07336771
Starting soon Phase 1/2

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

NCT07336771 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Phase
Phase 1/2
Started
2026-01
Last updated
2026-01-13

Condition(s) studied

Metastatic Breast CancerLocally Advanced Breast Cancer (LABC)

Investigational drug(s) / intervention(s)

JSKN016 Q2W →JSKN016 Q3W →D-0502 →

JSKN016 Q2W: 4 mg/kg, intravenous infusion, every 2 weeks

JSKN016 Q3W: 4 mg/kg, intravenous infusion, every 3 weeks

D-0502: 200 mg, oral, once daily

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of dose-limiting toxicities (DLTs) — From first dose through the end of Cycle 1 (approximately 21 days)
  • Objective Response Rate (ORR) — From first dose through treatment discontinuation, assessed up to 12 months
  • Safety and tolerability (TEAEs, TRAEs, SAEs) — From first dose until 30 days after the last dose of study treatment.

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer center Shanghai China

More Jiangsu Alphamab Biopharmaceuticals Co., Ltd trials in China

Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer Recruiting
Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC Recruiting
To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors Recruiting
JSKN033 Combination Therapy in Subjects With Advanced Cervical Cancer Starting soon
JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects Recruiting

Other trials for the same condition

Efficacy of Trastuzumab Deruxtecan in Metastatic Breast Cancer With Different HER2 Expression Patterns Recruiting
Real-World Study of Post-Resistance Treatment Strategies in Advanced Breast Cancer Following CDK4/6i, PIK3CA Inhibitors, or T-DXd Recruiting
Bortezomib Plus Cisplatin in Recurrent or Metastatic Breast Cancer Recruiting
Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer Active, not recruiting
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07336771 on ClinicalTrials.gov ↗ ← All trials in China