Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: SYS6023 in combination with KN026Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

The incidence of dose-limiting toxicity (DLT)

Time frame
At the end of Cycle 1 (each cycle is 21 days).
2

Frequency and severity of AEs and SAEs (according to NCI-CTCAE 6.0);

Time frame
Baseline up to 28 days post last dose, Up to approximately 3 years
3

Recommended Phase 2 Dose（RP2D）

Time frame
Up to approximately 3 years
4

Objective Response Rate (ORR)

Time frame
Up to approximately 3 years

Secondary outcomes

1

Maximum Plasma Concentration( Cmax)

Time frame
Up to approximately 3 years
2

Time to Maximum Plasma Concentration (Tmax)

Time frame
Up to approximately 3 years
3

Area Under the Serum Concentration Time Curve ( AUC)

Time frame
Up to approximately 3 years
4

Elimination half-life (t1/2)

Time frame
Up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Megalith Biopharmaceutical Co.,Ltd.

Lead sponsor

Source ClinicalTrials.gov
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