Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2027

Conditions
Inoperable Locally Advanced HER2-Negative Breast CancerMetastatic HER2-Negative Breast Cancer
Interventions
DRUG

JSKN016

JSKN016 is administered via intravenous infusion at doses of 5mg/kg or 6mg/kg every 3 weeks, starting on Day 1 of each cycle. If the 5mg/kg dose is well tolerated during the safety lead-in phase, the dose may be increased to 6mg/kg for subsequent cycles.

DRUG

Capecitabine

The drug is administered orally at a dose of 1000mg/m², twice daily for two weeks, followed by a one-week break. Treatment cycles repeat every three weeks.

DRUG

Paclitaxel (albumin bound)

The drug is administered intravenously at a dose of 125mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.

DRUG

Eribulin

The drug is administered intravenously at a dose of 1.4mg/m², with infusions on Day 1 and Day 8 of each treatment cycle. The treatment cycle is repeated every 3 weeks.

DRUG

Pembrolizumab

The drug is administered intravenously at a fixed dose of 200mg, with infusions on Day 1 of each 3-week treatment cycle.

Trial Locations (1)

Unknown

RECRUITING

Fudan University Shanghai Cancer center, Shanghai

All Listed Sponsors
lead

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

INDUSTRY

NCT06942234 - Study of JSKN016 Combination Therapy in Inoperable Locally Advanced or Metastatic HER2-Negative Breast Cancer | Biotech Hunter | Biotech Hunter