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Starting soon Phase 1/2

A Study of SYH2051 in Combination With Irinotecan Hydrochloride Liposome Injection in Subjects With Advanced Solid Tumors

NCT07911579 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2026-11-30
Last updated
2026-11-03

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

SYH2051 →Irinotecan Hydrochloride Liposome. →

SYH2051: SYH2051 is an oral medication taken once daily, with dosage selected according to the dose group.

Irinotecan Hydrochloride Liposome.: Irinotecan Hydrochloride Liposome is administered by intravenous infusion every 2 weeks (Q2W)

Study summary

This is a multicenter, open-label, dose-escalation and dose expansion, and cohort-expansion phase Ib/II clinical study to evaluate the safety and antitumor efficacy of SYH2051 in combination with Irinotecan Hydrochloride Liposome Injection in Patients with Advanced Solid Tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 1\. Fully understand the clinical study and voluntarily sign the written ICF; * 2\. Age ≥ 18 years; * 3\. Have at least one measurable lesion according to RECIST 1.1; * 4\. ECOG performance status score of 0 to 1; * 5\. Have adequate organ function; * 6\. Expected survival of at least 3 months; * 7\. Eligible participants of childbearing potential must agree to use a reliable method of contraception with their partner during the study and for at least 6 months after the last dose. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose; * 8\. Histologically or cytologically confirmed diagnosis of advanced solid tumors. Exclusion Criteria: * 1\. Patients with other active malignant tumors; * 2\. Uncontrolled serous effusions requiring frequent drainage or medical intervention within 14 days prior to the first dose; * 3\. Serious chronic or active infection; * 4\. Surgical on vital organs within 4 weeks prior to the first dose or planned systemic or local tumor resection during the study; * 5\. Untreated (including baseline findings) or unstable parenchymal metastases, spinal cord metastases or compression, carcinomatous meningitis; * 6\. History of non-infectious lung disease/pneumonitis requiring steroid hormone therapy or current interstitial lung disease/pneumonitis or suspected by imaging during screening; * 7\. History of significant cardiovascular disease; * 8\. History of immunodeficiency, Active hepatitis B or hepatitis C; * 9\. Known serious allergic reactions to the study drug or other ingredients and excipients in the formulation; * 10\. Pregnant or lactating women; * 11\. 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.

Primary outcome measure(s)

  • DLT — From Day 1 to Day 28
  • Frequency and severity of AE — From Day 1 to 12 months.
  • 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.

Trial sites (1)

FacilityCityRegionStatus
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07911579 on ClinicalTrials.gov ↗ ← All trials in China