Actively Recruiting
Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors
Led by CSPC Megalith Biopharmaceutical Co.,Ltd. · Updated on 2026-02-17
820
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors This study is a first-in-human phase I/II, multicenter, open-label, dose-escalation trial with PK expansion and cohort expansion, designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary anti-tumor efficacy of SYS6043 (a B7-H3-targeted antibody-drug conjugate) in patients with advanced/metastatic solid tumors. It consists of three parts: dose escalation, PK expansion and cohort expansion.
CONDITIONS
Official Title
Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years inclusive (subjects over 75 years eligible for Cohort 2 and Cohort 10)
- Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumors with disease recurrence or progression during or after standard therapy, intolerance to standard therapy, or no available standard therapy
- At least one extracranial measurable lesion per RECIST v1.1 (special assessment for mCRPC with bone metastases)
- Expected survival of at least 3 months
- ECOG performance status 0 or 1 with no deterioration within 28 days prior to enrollment (ECOG 2 allowed for Cohort 2 and Cohort 10)
- Left ventricular ejection fraction (LVEF) ≥ 50% by ECHO or MUGA within 28 days prior to enrollment
- Adequate major organ function within 7 days prior to enrollment including hematology, blood biochemistry, and coagulation
- Recovery to ≤ Grade 1 toxicity from prior therapy per CTCAE v5.0 or baseline levels (except certain non-safety-risk toxicities)
- Sufficient washout period from prior anti-tumor therapies before first study drug administration
- Willingness to provide tumor tissue samples or undergo biopsy for biomarker analysis
- Negative pregnancy test within 7 days prior to randomization for females of childbearing potential
- Agreement to use contraception during study and for 7 months after last dose; no breastfeeding during study
- Signed informed consent
- Advanced or metastatic solid tumors with failure of standard systemic therapy
You will not qualify if you...
- Prior treatment with B7-H3-targeted therapy
- Prior treatment with irinotecan, topotecan, other topoisomerase I inhibitors, or topoisomerase inhibitor antibody-drug conjugates (for Phase I PK expansion and Phase II cohort expansion)
- History of symptomatic congestive heart failure (NYHA Class II-IV) or severe cardiac arrhythmias requiring treatment
- History of myocardial infarction or unstable angina within 6 months prior to enrollment
- Prolonged QTcF >470 ms on three ECG assessments
- Inability or unwillingness to stop medications that prolong QT interval
- History or current interstitial lung disease or non-infectious pneumonia requiring glucocorticoids
- History of significant pulmonary disease or need for supplemental oxygen within 3 months prior to treatment
- Autoimmune, connective tissue, or inflammatory lung diseases
- Uncontrolled infections requiring intravenous antimicrobial therapy
- Known HIV infection or active syphilis requiring systemic therapy
- Active viral hepatitis infection as defined by viral markers and viral load
- Lactating women or women confirmed pregnant within 7 days prior to enrollment
- Presence of spinal cord compression or active brain/meningeal metastases without stability
- History of multiple primary malignancies within 3 years except certain adequately treated cancers
- History of substance abuse or any medical condition increasing safety risk or study interference
- Use of strong CYP3A4 inhibitors or inducers within 14 days prior to first dose or need during study
- Known hypersensitivity to study drug components
- Presence of symptomatic pleural, pericardial, or peritoneal effusions requiring drainage
- Any other investigator-determined reasons making participant unsuitable for study enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
C
Clinical Trials Information Group officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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