A Study of SYS6051 in Subjects With Advanced Solid Tumors

Starting soon · Phase 1

Conditions studied: Advanced Solid Tumors

In brief

This is a multicenter, open-label, dose-escalation and backfill, and cohort-expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor efficacy of SYS6051 in participants with advanced solid tumors.

Key facts

Study ID

NCT07591285

Run by

CSPC Megalith Biopharmaceutical Co.,Ltd.

People needed

114

Starts

2026-05-12

Expected to finish

2028-06-30

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Fully understand the clinical study and voluntarily sign the written ICF;
• Age ≥ 18 years;
• Have at least one measurable lesion according to RECIST 1.1;
• ECOG performance status score of 0 to 1;
• Have adequate organ function;
• Expected survival of at least 3 months;
• Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 4 months (males) or 7 months (females) after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose;
• Histologically or cytologically confirmed diagnosis of advanced solid tumors. -

You may not qualify if…

• Presence of high bleeding risk factors; 2. Presence of active ocular disease; 3. Patients with other active malignant tumors; 4. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose; 5. Serious chronic or active infection; 6. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study; 7. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis; 8. History of non-infectious lung disease/pneumonitis requiring steroid hormone therapy or current interstitial lung disease/pneumonitis or suspected by imaging during screening; 9. History of significant cardiovascular disease; 10. History of immunodeficiency, Active hepatitis B or hepatitis C; 11. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation; 12. Pregnant or lactating women; 13. Presence of other conditions that could interfere with the participant 's participation in study procedures or would not be in the best interest of the participant' s participation in the study or affect the study results: such as a history of mental illness, drug use, or drug abuse, any other clinically significant disease or condition.

Full record on ClinicalTrials.gov

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