A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer
ConditionAdvanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This is an open-label, multicenter Phase II clinical study conducted in subjects with advanced breast cancer.
Eligibility criteria
Qualifiers
1. Age ≥ 18 years old;
3. Sufficient tumor specimens must be provided for biomarker testing (human epidermal growth factor receptor 3-HER3), preferably obtained during or after the most recent treatment period; During safety run-in period, subjects who cannot provide sufficient tissue samples may be screened after sponsor's evaluation and approval;
4. Documented disease progression or intolerability with the most recent systemic anti-tumor treatment;
5. According to RECIST 1.1, at least one evaluable lesion (safety run-in period) or measurable lesion (cohort expansion phase);
Disqualifiers
1. Prior treatment with HER3-targeted ADC therapy;
2. Applicable to Cohort 1: a. Prior treatment with any topoisomerase I inhibitor-loaded ADC therapy; b. Current presence or impending visceral crisis that has caused or may cause impending organ damage and/or other life-threatening complications;
3. Applicable to Cohort 2: a. Prior exposure to anthracyclines with cumulative dose exceeding 360 mg/m²doxorubicin equivalent; b. LVEF once dropped to < 40% during prior anti-HER2 drug therapy, or symptomatic CHF occurred;
4. History of other malignancies within 3 years before randomization/first dose or concurrent active malignancies (except cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc., which are allowed to enroll);
Trial design
Treatments tested in this trial
- SYS6023
- KN026
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov