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NCT Number: NCT07591285

A Study of SYS6051 in Subjects With Advanced Solid Tumors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Exclusion criteria

  • 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.

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Treatment and study plan

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.

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: From Day 1 to Day 21

  2. Frequency and severity of AE

    Time frame: From Day 1 to 30 days after last dose.

  3. Maximal tolerable dose (MTD)

    Time frame: From Day 1 to 12 months.

  4. Recommended phase 2 dose (RP2D)

    Time frame: From Day 1 to 12 months.

  5. ORR

    Time frame: From Day 1 to 12 months.

Secondary outcomes

  1. Cmax

    Time frame: From Day 1 to 12 months.

  2. AUCss,

    Time frame: From Day 1 to 12 months.

  3. ORR

    Time frame: From Day 1 to 12 months.

  4. PFS

    Time frame: From Day 1 to 12 months.

  5. OS

    Time frame: From Day 1 to 18 months.

  6. Positive rate for ADA

    Time frame: From Day 1 to 18 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Information Group

CONTACT

[email protected]

86-0311-69085587

Sponsors and collaborators

Lead sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Industry

Registry information

Official study title

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of SYS6051 in Patients With Advanced Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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