Actively Recruiting
Phase I/II Dose-Escalation, PK Expansion and Cohort Expansion Study Evaluating Safety, Pharmacokinetics, and Efficacy of SYS6043 in Female Patients With Advanced/Metastatic Solid Tumors
Led by CSPC Megalith Biopharmaceutical Co.,Ltd. · Updated on 2026-02-17
820
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SYS6043, a B7-H3-targeted antibody-drug conjugate, in patients with advanced or metastatic solid tumors that have recurred or progressed after standard treatment or have no available standard therapy. This first-in-human phase I/II trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor effects of SYS6043. The study is sponsored by CSPC Megalith Biopharmaceutical Co.,Ltd. and includes dose escalation, PK expansion, and cohort expansion phases. Participants will receive SYS6043 as a subcutaneous injection in a non-randomized, open-label setting. The trial involves three parts: dose escalation to determine the maximum tolerated dose and recommended phase 2 dose, pharmacokinetic expansion to further study the drug's behavior in the body, and cohort expansion to evaluate efficacy. Only female participants aged 18 to 75 years (with some cohorts allowing older participants) who meet eligibility criteria will be enrolled. During the study, participants will be monitored for adverse events and treatment responses over up to three years. Researchers will assess tumor response using objective response rate, duration of response, disease control rate, time to response, progression-free survival, and overall survival. Evaluations will include laboratory tests, imaging, biomarker analysis, and cardiac function assessments. Participants will also be followed for immune response to the drug and protein expression in tumors. Safety and tolerability will be carefully tracked throughout the trial.
CONDITIONS
Brief 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 eligible in some cohorts)
- Female gender
- Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumors
- Disease recurrence or progression during or after standard systemic therapy, intolerance to standard therapy, or no available standard therapy
- At least one extracranial measurable lesion per RECIST v1.1
- Expected survival of 3 months or longer
- ECOG performance status 0 or 1 (some cohorts allow status 2)
- Left ventricular ejection fraction ≥ 50% by echocardiography or radionuclide ventriculography within 28 days prior to enrollment
- Adequate major organ function within 7 days prior to enrollment, including hematology, blood biochemistry, and coagulation
- Recovery from prior therapy toxicities to Grade 1 or baseline (except certain mild toxicities)
- Sufficient washout period from prior anti-tumor therapies
- Willingness to provide tumor samples or undergo biopsy for biomarker detection
- Negative pregnancy test for females of childbearing potential within 7 days prior to randomization
- Agreement to use adequate contraception during the study and for 7 months after last dose
- Voluntary signed informed consent
- Advanced/metastatic solid tumors with failure of standard systemic therapy
You will not qualify if you...
- Prior receipt of B7-H3-targeted therapy
- Prior treatment with irinotecan, topotecan, other topoisomerase I inhibitors, or related antibody-drug conjugates (for certain study stages)
- History of symptomatic congestive heart failure (NYHA Class II-IV) or severe arrhythmias requiring treatment
- Myocardial infarction or unstable angina within 6 months prior to enrollment
- Prolonged QT interval >470 ms on ECG
- Inability or unwillingness to stop medications that prolong QT interval
- History or current interstitial lung disease or non-infectious pneumonia requiring glucocorticoids
- 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 antibiotics or antifungal agents
- HIV infection or active syphilis requiring therapy
- Active viral hepatitis with significant viral load
- Lactating or pregnant women
- Presence of spinal cord compression or active brain/meningeal metastases (with some exceptions)
- Multiple primary malignant tumors within 3 years except certain treated skin or in situ cancers
- History of substance abuse or other conditions increasing safety risk or interfering with participation
- Use of strong CYP3A4 inhibitors or inducers within 14 days prior to first dose
- Known hypersensitivity to study drug ingredients
- Symptomatic pleural, pericardial, or peritoneal effusion
- Any other investigator-assessed reasons for unsuitability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive SYS6043 as a subcutaneous injection to evaluate its safety and effectiveness for advanced/metastatic solid tumors.
Visits scheduled according to treatment cycles and assessments over the treatment period
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
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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