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Trial Title: Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors

NCT ID: NCT05740215

Condition: Solid Tumors

Conditions: Official terms:
Neoplasms
Lenvatinib

Conditions: Keywords:
F520
PD-1

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: F520
Description: F520 is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2)
Arm group label: F520 combined with lenvatinib

Intervention type: Drug
Intervention name: Lenvatinib
Description: Lenvatinib capsules
Arm group label: F520 combined with lenvatinib

Summary: This is a multicenter, open-label, phase Ib/II study on the efficacy and safety of F520 combined with lenvatinib in the treatment of patients with advanced solid tumors. About 138~158 patients with advanced solid tumors plan to be enrolled in about 30 study sites of the study. Part I: Phase Ib study evaluating the safety and tolerability of F520 combined with lenvatinib in patients with advanced solid tumors. Part II: Phase II study of F520 combined with lenvatinib in endometrial cancer and cervical cancer.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Phase Ib: 1. Male or female aged ≥18 years and ≤75 years old; 2. Study population: confirmed by histological and/or cytological examination patients with solid tumors (endometrial cancer, cervical cancer, non-small cell lung cancer, urothelial carcinoma, etc.), patients with metastatic solid tumors who have failed (disease progression or intolerance) after adequate standard treatment or lack effective treatments; 3. Expected survival period ≥ 12 weeks; 4. ECOG 0-1 points; 5. Blood pressure (BP) is adequately controlled with or without antihypertensive drugs, defined as BP ≤ 150/90 mmHg and unchanged antihypertensive drugs within 1 week prior to enrollment; 6. Vital organ functions meet the following requirements (Reception of granulocyte colony-stimulating factor (G-CSF) or pegylated granulocyte colony-stimulating factor (PEG-G-CSF) or blood transfusion within 14 days prior to laboratory tests is not permitted for prophylactic use): Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90 g/L, platelet count (PLT) ≥ 75 ×109/L, lymphocyte percentage≥10%; liver function: total bilirubin level (TBIL)≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40mL/min (Cr>1.5×ULN); Coagulation function: international normalized ratio (INR) ≤1.5×ULN; 7. Aagree to provide archived tumor tissue samples Or fresh tissue samples; 8. Those who understand and voluntarily sign the written informed consent. Phase II: 1. Women aged ≥18 years and ≤75 years old; 2. Study population: Cohort 1: Patients with recurrent or metastatic endometrial cancer (except carcinosarcoma) who have progressed after receiving at least one line of treatment, and the number of previous platinum-containing treatment lines is ≤ 2; Cohort 2: patients with recurrent or metastatic cervical cancer (Squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma) who have progressed after receiving at least one line of platinum-containing regimens and adenosquamous carcinoma); those who progressed during or within 6 months after receiving platinum-containing regimen neoadjuvant or adjuvant chemotherapy can also be included; 3. Expected survival ≥ 12 weeks; 4. According to the RECIST1.1 standard, the subject patients must have at least one measurable target lesion (extranodal lesions: long diameter ≥ 10mm; intranodal lesions: short diameter ≥ 15mm) by enhanced CT and/or enhanced MRI; 5. ECOG 0-1 points; 6. Adequate control of blood pressure (BP) with or without antihypertensive drugs, defined as BP ≤ 150/90 mmHg and antihypertensive drugs remained unchanged within 1 week before enrollment; 7. Vital organ functions meet the following requirements (Reception of granulocyte colony-stimulating factor (G-CSF) or pegylated granulocyte colony-stimulating factor (PEG-G-CSF) or blood transfusion within 14 days prior to laboratory tests is not permitted for prophylactic use): Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L, hemoglobin (HGB) ≥ 90 g/L, platelet count (PLT) ≥ 75 ×109/L, lymphocyte percentage≥10%; liver function: total bilirubin level (TBIL)≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥40mL/min (Cr>1.5×ULN); Coagulation function: international normalized ratio (INR) ≤1.5×ULN; 8. Those who agree to provide archived tumor tissue samples or fresh tissue samples; 9. Those who understand and voluntarily sign the written informed consent. Exclusion Criteria: 1. Those who have received systemic tumor therapy of radiotherapy, chemotherapy, traditional Chinese medicine, hormone therapy, surgery, targeted therapy or antibody drugs within 28 days (or 5 half-lives of the drug, whichever is shorter) before the first dose; Those whose toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except alopecia); 2. Those who have previously received any angiogenic drugs that directly target VEGF (Subjects who have only used bevacizumab in the past can be enrolled), anti-PD-1, anti-PD-L1, anti-PD-L2 or any other Antibody or drug therapy that specifically targets T cell co-stimulation or checkpoint pathways; 3. Subjects with central nervous system (CNS) metastases, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery, or radiosurgery) and have stopped corticosteroid therapy at least 4 weeks prior to the start of study treatment; 4. Inability to swallow or disease/surgery significantly affects gastrointestinal function, such as malabsorption syndrome, gastrectomy or small bowel resection, bariatric surgery, symptomatic inflammatory bowel disease, etc.; 5. Partial or complete intestinal obstruction or intestinal obstruction occurred within 1 month before the first administration; 6. Have suffered from interstitial lung disease, non-infectious pneumonia or uncontrolled lung disease in the past 3 years, including but not limited to pulmonary fibrosis, acute lung disease, etc.; 7. Those with uncontrollable or severe cardiovascular diseases, such as New York Heart Association (NYHA) congestive heart failure above grade II, unstable angina, myocardial infarction and other cardiovascular diseases occurring within 6 months before the first administration; 8. QTcF ≥ 480 milliseconds (QT interval must use Fridericia formula for heart rate correction [QTcF]); 9. Within 3 months before the first dose, there were clinically significant hematuria, hematemesis or hemoptysis (>2.5 mL red blood), or other medical history of significant bleeding (such as pulmonary hemorrhage); 10. Those with thrombosis who need treatment in the acute phase; 11. Active hepatitis patients (HBV DNA>2000 IU/mL or 1000 copies of chronic hepatitis B or chronic HBV carriers; HCV positive and HCV-RNA positive hepatitis C patients); human immunodeficiency virus (HIV) antibody positive; Treponema pallidum (TP) antibody positive; 12. Subjects with urine protein>1+ receive 24-hour urine protein quantification, urine protein ≥1g/24 hours; 13. Those with a known history of contraindications or hypersensitivity to any test drug or any known excipients; 14. Those who have had organ transplantation in the past or received autologous stem cell transplantation within 3 months before the first administration; 15. Those with a history of other malignant tumors within the past 3 years, except locally curable cancers (radical melanoma, basal or squamous cell carcinoma, carcinoma in situ of the bladder or cervix); 16. Immunosuppressant, systemic or local hormone therapy has been used within 14 days before the first administration to achieve the purpose of immunosuppression (daily dose equivalent to prednisone > 10 mg of systemic corticosteroids); 17. Those with a history of drug abuse and alcoholism within 6 months before the first administration; 18. Active autoimmune disease requiring systemic treatment within the past 2 years (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs), alternative therapy (such as physiological corticosteroid replacement therapy for thyroxine, insulin, or adrenal or pituitary insufficiency, etc.) is not considered a systemic treatment; 19. Those who received (attenuated) live vaccines within 30 days before the first administration (except for inactivated influenza vaccines such as injectable seasonal influenza vaccines and COVID-19 vaccines); 20. Pregnant or breastfeeding women, female subjects of childbearing age or male subjects whose partner is a woman of childbearing age do not agree to use highly effective methods of contraception during the study period and within 6 months after the last study drug treatment; 21. Those judged by the researchers to be unsuitable for enrollment.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Chongqing University Cancer Hospital

Address:
City: Chongqing
Zip: 400030
Country: China

Status: Recruiting

Contact:
Last name: Xiaohua Tang

Phone: 023-65075696
Email: czll5545@126.com

Investigator:
Last name: Qi zhou
Email: Principal Investigator

Investigator:
Last name: Yongsheng Li
Email: Principal Investigator

Start date: May 23, 2022

Completion date: May 22, 2024

Lead sponsor:
Agency: Shandong New Time Pharmaceutical Co., LTD
Agency class: Industry

Source: Shandong New Time Pharmaceutical Co., LTD

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05740215

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