Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors (NCT07424547)
Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: BRCR Global — Plantation, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- BRCR Global — Plantation, Florida
- Florida Clinical Trials Group — Plantation, Florida
- NEXT Oncology Austin — Austin, Texas
- NEXT Oncology San Antonio — San Antonio, Texas
- NEXT Oncology Virginia — Fairfax, Virginia
📞 Contact the Study Coordinator
Phone: (609) 356-0210
Email: clinicaltrials.gov@cspcus.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.