Actively Recruiting
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
Led by Conjupro Biotherapeutics, Inc. · Updated on 2026-04-07
386
Participants Needed
5
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works. Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment. * Have safety follow-up (SFU), and long-term follow-up. * Be followed until progression.
CONDITIONS
Official Title
Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the time of signing informed consent.
- Have advanced, unresectable, or metastatic solid tumors confirmed by histology or cytology.
- Disease recurrence or progression during or after standard treatments, or no standard therapies available or tolerated.
- Have at least one measurable tumor lesion according to RECIST V1.1 criteria.
- For metastatic castration-resistant prostate cancer with only bone metastases, enrollment considered after discussion with medical monitor.
- Expected life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 without worsening in the past 28 days.
- Left ventricular ejection fraction (LVEF) of 50% or higher as shown by recent ECHO or MUGA scan within 28 days prior to enrollment.
You will not qualify if you...
- Prior treatment with B7-H3 targeted therapy.
- Previous use of topoisomerase inhibitor antibody-drug conjugates (e.g., trastuzumab deruxtecan).
- Symptomatic congestive heart failure (NYHA Class II-IV) or history of severe arrhythmia needing treatment.
- History of heart attack or unstable angina within 6 months before enrollment.
- Prolonged QT interval (>470 ms corrected by Fridericia formula) on three ECG exams.
- Unable or unwilling to stop medications that prolong QT interval.
- History or current interstitial lung disease needing glucocorticoid treatment, or suspected by imaging.
- History of significant lung disorders including recent pulmonary embolism, severe asthma, severe COPD, restrictive lung disease, or need for supplemental oxygen.
- Autoimmune, connective tissue, or inflammatory lung diseases (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis).
- Uncontrolled infections requiring intravenous antibiotics, antivirals, or antifungals.
- Active significant infections including hepatitis C with high viral load, HIV positive, or confirmed syphilis.
- Positive hepatitis B surface antigen with high viral load; must have received at least 2 weeks of antiviral treatment before first dose and agree to continue during study.
- Lactating women or women pregnant within 7 days prior to enrollment.
- Presence of spinal cord compression or active brain metastases requiring treatment or corticosteroids.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
BRCR Global
Plantation, Florida, United States, 33322
Actively Recruiting
2
Florida Clinical Trials Group
Plantation, Florida, United States, 33322
Actively Recruiting
3
NEXT Oncology Austin
Austin, Texas, United States, 78758
Actively Recruiting
4
NEXT Oncology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
5
NEXT Oncology Virginia
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
D
Director, Clinical Operations
CONTACT
R
Regulatory Operations Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here