A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.
About this trial
This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors.
Eligibility criteria
Qualifiers
Age ≥ 18 years;
Histologically and/or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumor;
Sufficient archived or fresh tumor tissue samples must be provided for HER3 testing, among others;
Medical documentation must be provided before the first dose to clarify the following molecular typing information: HER2, HR receptor (including estrogen receptor (ER) and progesterone receptor (PR) ) expression for breast cancer participants, and Epidermal Growth Factor Receptor (EGFR) mutation, Anaplastic Lymphoma Kinase (ALK) fusion, ROS Proto-Oncogene 1, receptor tyrosine kinase (ROS1) fusion, B-Raf Proto-Oncogene, serine/threonine kinase (BRAF) V600 mutation, Neurotrophic Tyrosine Receptor Kinase (NTRK) fusion, Neurotrophic Tyrosine Receptor Kinase (RET) rearrangement, HER2 mutation, MET Proto-Oncogene（Met）exon14 skipping mutation, Met amplification, KRAS Proto-Oncogene, GTPase G12C（KRAS G12c） mutation status for non-small cell lung cancer (NSCLC) participants;
Disqualifiers
Severe cardiac arrhythmia or conduction abnormality requiring clinical intervention, such as ventricular arrhythmia, grade II-III atrioventricular block, etc.;
Average QT interval corrected by Fridericia's formula (QTcF) > 450 ms on three resting 12-lead Electrocardiogram;
Acute coronary syndrome, congestive heart failure, stroke, or other grade 3 or higher cardiovascular events within 6 months before the first dose;
New York Heart Association (NYHA) classification ≥ Class II;
Trial design
Treatments tested in this trial
- SYS6023
Treatment groups
400 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov