Actively Recruiting
A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors
Led by CSPC Megalith Biopharmaceutical Co.,Ltd. · Updated on 2025-08-08
400
Participants Needed
2
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, dose-escalation and cohort-expansion, multicenter Phase I study involving participants with advanced solid tumors.
CONDITIONS
Official Title
A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed locally advanced unresectable or metastatic malignant solid tumor
- Ability to provide archived or fresh tumor tissue for HER3 testing
- Available medical documentation for molecular typing relevant to tumor type
- Meet specific cohort criteria based on tumor type and molecular markers, including prior lines of therapy
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function as defined by blood counts, liver and kidney function, coagulation tests, and heart function
- Fertile participants agree to use reliable contraception during and for 6 months after the study; females of childbearing potential must have a negative pregnancy test
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Known symptomatic or uncontrolled central nervous system or meningeal metastases (stable metastases allowed)
- Previous treatment with HER3-targeting antibody-drug conjugates
- Unresolved adverse reactions from prior anti-tumor treatments above Grade 1 severity (except alopecia)
- Recent receipt of certain therapies including antibody-based treatments, radiotherapy, immunotherapy, chemotherapy, targeted therapy, hormone therapy, or traditional Chinese medicine within specified timeframes before dosing
- Participation in other interventional clinical trials (except observational or follow-up)
- Major surgery or invasive intervention within 28 days before dosing
- Known severe allergies to study drug or its components
- Active infections requiring intravenous antibacterial, antifungal, or antiviral treatment
- Uncontrolled fluid buildup requiring frequent drainage
- History of immunodeficiency including HIV positivity
- Active or high viral load hepatitis B or C infection
- Severe cardiovascular disease or conditions increasing risk of heart rhythm problems
- History or suspicion of interstitial lung disease or pneumonitis
- Risk or evidence of gastrointestinal bleeding, obstruction, or persistent vomiting
- Use of strong CYP3A4 enzyme inducers/inhibitors or certain drug transporter inhibitors
- Current psychiatric disorders affecting compliance
- Use of long-term immunosuppressive therapy or daily systemic steroids (except topical)
- Pregnant or breastfeeding women
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Affiliated Tumor Hospital of Harbin
Harbin, Heilongjiang, China, 150000
Actively Recruiting
2
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200000
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
7
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