A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer

Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Study ID
NCT07597629
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SYS6023 — DRUG
    SYS6023 is a novel antibody-drug conjugate (ADC) targeting HER3, administered via intravenous infusion.
  • KN026 — DRUG
    KN026 is an antibody targeting HER2, administered via intravenous infusion.

Study Details

This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.

Key Dates

First listed
May 19, 2026
Start date
May 25, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
May 30, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SYS6023 in combination with KN026
    Patients with advanced breast cancer receiving SYS6023 in combination with KN026 treatment.

Primary Outcome Measure

The incidence of dose-limiting toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days). ]

Central Contacts

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