Status:
NOT_YET_RECRUITING
A Study of Simmitinib Plus SG001 in Advanced Solid Tumors
Lead Sponsor:
Shanghai Runshi Pharmaceutical Technology Co., Ltd
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dos...
Eligibility Criteria
Inclusion
- Have fully understood and voluntarily sign the ICF for this study;
- Age of 18-75 years (inclusive);
- Dose escalation phase: patients with histologically or cytologically confirmed inoperable or metastatic advanced solid tumors;
- Dose expansion phase: patients who have failed standard treatment (PD or intolerable toxicity after treatment), have no available standard treatment.According to the previous data, the specific tumor cohort was expanded.
- In the expansion phase, patients should agree to provide tissue specimens for detection of PD-L1 expression levels and/or MSI or dMMR status;
- At least one measurable lesion according to RECIST 1.1;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-1;
- Adequate organ function, defined as:
- Neutrophil count (ANC) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 100× 10\^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (≤ 5.0 × ULN for patients with liver metastases); Serum total bilirubin (TBIL) ≤ 1.5 × ULN; Serum creatinine ≤ 1.5 × ULN; Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio(INR)≤1.5 × ULN; Thyroid Stimulating Hormone (TSH)≤ULN; Left ventricular ejection fraction (LVEF)≥50%; Male and female patients of childbearing age must agree to take effective contraceptive measures during treatment and within 6 months after the last dose of treatment.
Exclusion
- Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
- Urine protein ≥ ++ and 24 h urine protein \> 1.0g at screening period;
- Symptomatic central nervous system (CNS) metastases or meningeal metastases;
- Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;
- History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma;
- Patients with other types of malignant tumors within 5 years prior to the screening, except for radically resected, non-recurrent skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ, or other carcinoma in situ;
- Patients with any active autoimmune disease requiring systemic therapy within 2 years prior to the first dose;
- Patients with bleeding tendency; active bleeding or a history of heavy bleeding within the past 6 months;
- Presence of any severe and/or uncontrolled disease before starting treatment;
- Any active infection requiring antibiotics or hormones systemic treatment by intravenous infusion within 14 days prior to the first dose;
- Dose expansion phase: Prior systemic therapy with immunosuppressants or immunoagonists targeting PD-1, PD-L1, CTLA-4, etc;
- Dose expansion phase: Prior systemic therapy with Antiangiogenic drugs including Anlotinib, Afatinib , Lenvatinib, Sorafenib and Fruquintinib, etc;
Key Trial Info
Start Date :
January 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06132217
Start Date
January 30 2024
End Date
January 30 2027
Last Update
November 15 2023
Active Locations (1)
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1
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100000