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

Alphamab

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Locally Advanced Breast Cancer (LABC); Metastatic Breast Cancer

Treatments: Drug: JSKN016 Q3W; Drug: JSKN016 Q2W; Drug: D-0502

Study type: Interventional

Funder types: Industry

Identifiers

NCT07336771

JSKN016-204

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

JSKN016 Q2W + D-0502

Experimental group

Treatment:

Drug: D-0502

Drug: JSKN016 Q2W

JSKN016 Q3W + D-0502

Experimental group

Treatment:

Drug: D-0502

Drug: JSKN016 Q3W