Starting soon
Phase 1/2
A Study of SYH2051 in Combination With Irinotecan Hydrochloride Liposome Injection in Subjects With Advanced Solid Tumors
Condition(s) studied
Advanced Solid Tumors
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
| Tianjin Medical University Cancer Institute & Hospital |
Tianjin |
Tianjin Municipality |
|
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