Actively Recruiting
A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors
Led by CSPC Megalith Biopharmaceutical Co.,Ltd. · Updated on 2025-05-14
180
Participants Needed
1
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.
CONDITIONS
Official Title
A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosed with advanced solid tumors confirmed by histology or cytology who have failed or are intolerant to standard therapy or have no standard care options
- For cohort expansion: subjects with small cell lung cancer who failed or were intolerant to at least one platinum-containing chemotherapy, or subjects with DLL3-positive malignant solid tumors meeting the above criteria
- At least one measurable lesion as defined by RECIST v1.1
- ECOG performance status of 0 or 1
- Life expectancy of 3 months or more
- Laboratory values meeting specific criteria for neutrophils, platelets, hemoglobin, liver enzymes, bilirubin, creatinine, and coagulation parameters
- Fertile males and females must use reliable contraception during the study and for 9 months after last dose
- Females aged 18-60 must have a negative pregnancy test within 7 days before first dose
- Ability to understand and voluntarily sign informed consent
You will not qualify if you...
- Received systemic antitumor therapy within 4 weeks before first dose, except specific allowed oral or traditional Chinese medicines
- Use of strong CYP3A4 inhibitors or inducers within 2 weeks before first dose or during study
- Prior treatment with antibody-drug conjugates containing topoisomerase I inhibitors
- Use of systemic corticosteroids or immunosuppressants within 2 weeks before treatment initiation, except certain permitted steroid uses
- Received transfusion or growth factor therapies within 2 weeks before first dose
- Use or requirement of QT-prolonging/shortening drugs within 7 days before first dose or during study
- History of severe cardiovascular or cerebrovascular disease
- History of other primary malignancies except certain cured localized tumors or those without recurrence for 5 years
- Active pneumonia or interstitial lung disease
- Uncontrolled serous effusions requiring frequent medical intervention
- Brain metastases or spinal cord compression unless stable and treated
- Severe unhealed wounds, recent major surgery, or planned elective surgery during study
- Active hepatitis B or C infection
- Active tuberculosis, positive for HIV or immunodeficiency conditions
- Significant bleeding tendency or high risk of gastrointestinal bleeding
- Active infection requiring medication or unexplained fever above 38.5°C
- History of substance abuse or alcoholism
- Pregnancy or lactation at screening
- Persistent adverse reactions from prior cancer therapy not recovered to mild levels
- Investigator's judgment deeming participant unsuitable for study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jilin Cancer Hospital
Changchuan, Jilin, China, 130021
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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