A Study of SYS6051 in Subjects With Advanced Solid Tumors

NCT07591285 | Not Yet Recruiting Phase 1

• 1 other identifier: SYS6051-001
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Dose limiting toxicity (DLT)

  From Day 1 to Day 21

• Frequency and severity of AE

  From Day 1 to 30 days after last dose.

• Maximal tolerable dose (MTD)

  From Day 1 to 12 months.

• Recommended phase 2 dose (RP2D)

  From Day 1 to 12 months.

• ORR

  From Day 1 to 12 months.

Secondary Outcomes (6)

• Cmax

  From Day 1 to 12 months.

• AUCss,

  From Day 1 to 12 months.

• ORR

  From Day 1 to 12 months.

• PFS

  From Day 1 to 12 months.

• OS

  From Day 1 to 18 months.

Study Arms (1)

SYS6051

EXPERIMENTAL

Drug: SYS6051

Interventions

SYS6051 DRUG

SYS6051 is administered by intravenous infusion every 3 weeks (Q3W). The doses administered for the first and subsequent visits of SYS6051 will be calculated based on the weight at screening/baseline and prior to dosing at subsequent visits.

SYS6051

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Central Study Contacts

Clinical Trials Information Group

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is the first-in-human phase I study of SYS6051 and this study consists of two part: a dose escalation and backfill part and a cohort expansion part.

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: May 12, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05