A Study of SYS6051 in Subjects With Advanced Solid Tumors

Официальное название

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

Обзор

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.

Вмешательства

• Препарат SYS6051
  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.

Первичные конечные точки

• Dose limiting toxicity (DLT) [Срок оценки: From Day 1 to Day 21]
• Frequency and severity of AE [Срок оценки: From Day 1 to 30 days after last dose.]
• Maximal tolerable dose (MTD) [Срок оценки: From Day 1 to 12 months.]
• Recommended phase 2 dose (RP2D) [Срок оценки: From Day 1 to 12 months.]
• ORR [Срок оценки: From Day 1 to 12 months.]

Вторичные конечные точки (6)

• Cmax [Срок оценки: From Day 1 to 12 months.]
• AUCss, [Срок оценки: From Day 1 to 12 months.]
• ORR [Срок оценки: From Day 1 to 12 months.]
• PFS [Срок оценки: From Day 1 to 12 months.]
• OS [Срок оценки: From Day 1 to 18 months.]
• Positive rate for ADA [Срок оценки: From Day 1 to 18 months.]

Критерии участия

Критерии включения

• 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. -

Критерии исключения

1\. 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.

\-

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07591285 · SYS6051-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗