Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Neoplasm Metastasis

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplastic Processes

Lymphosarcoma

Primary Central Nervous System Lymphoma

F520

It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of F520 for the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL).

A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)

A Phase 2, Open-label, Single-arm, Multicenter Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)

Response assessment will be performed according to modified IPCG response. criteria on contrastenhanced cranial MRI-scans.

Response assessment will be performed according to modified IPCG response.

Based on IRC and the investigator assessments.

Shandong New Time Pharmaceutical Co., LTD

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Lymphoma, Non-Hodgkin

Peripheral T-cell Lymphoma

It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of F520 for the treatment of relapsed and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of F520.

The Efficacy and Safety of F520 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).

A Phase 2, Open-label, Single-arm, Multicenter Study of the Efficacy and Safety of F520 in Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).

To evaluate the efficacy of F520 as defined by objective response rate (evaluated by IRC) in patients with relapsed or refractory PTCL.

To evaluate the efficacy of F520 as defined by objective response rate (evaluated by investigator) in patients with relapsed or refractory PTCL.

To evaluate the efficacy of F520 as defined by completed response rate (evaluated by investigator/IRC) in patients with relapsed or refractory PTCL.

To evaluate the duration of response (DOR) of F520 in patients with relapsed or refractory PTCL.

To evaluate the duration from the first administration to death because of any reason in patients with relapsed or refractory PTCL.

To evaluate the efficacy of F520 as defined by progression-free survival, in patients with relapsed or refractory PTCL.

To evaluate the efficacy of F520 as defined by disease control rate, in patients with relapsed or refractory PTCL.

To evaluate the efficacy of F520 as defined by time to response in patients with relapsed or refractory PTCL.

Carcinoma

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Transitional Cell Carcinoma

This is a multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody F520 in participants with locally advanced or metastatic Urothelial Cancer (UC).

A Phase Ⅱ Study of F520 in Patients With Urothelial Carcinoma

A Phase 2, Open-label, Single-arm，Multicenter Study of F520 in Patients With Urothelial Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Lenvatinib

Immunoglobulins

Protein Kinase Inhibitors

Enzyme Inhibitors

F520:

F520 (200 mg) administered intravenously (IV) on Day 1 of each 21-day cycle in the phase Ib and II studies until progressive disease, unacceptable toxicity or ending treatment for other reasons. \[Time Frame: up to 2 years post infusion\]

Lenvatinib:

In the phase Ib study, three dose groups of 20 mg, 16 mg and 12 mg lenvatinib were designed. 3 to 6 subjects are expected to be enrolled in each dose group according to observed DLT. The designated dose of lenvatinib administered orally once daily (QD) according to the assigned dose group.

In the phase II study, lenvatinib administered orally once daily (QD) according to recommended phase II dose (RP2D) obtained in phase Ib study.

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)

Qi zhou, MMed

Xiaohua Tang

Qi zhou

Yongsheng Li

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.

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

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

Phase Ib: The incidence of adverse events/serious adverse events, their correlation with the trial drug and their severity.

Phase Ib: Assess the incidence of dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).

Phase II: Objective Response Rate (ORRW24) evaluated by the Independent Review Committee (IRC) based on RECIST 1.1.

Phase Ib: To determine the preliminary efficacy by evaluating the objective response rate (ORR) of F520 combined with lenvatinib in patients with advanced solid tumors (The last subject completed the 8th cycle of administration and completed the corresponding visits).

Phase Ib: To evaluate the pharmacokinetic characteristics of F520 and lenvatinib in patients with advanced solid tumors.

Phase II: The objective response rate evaluated by the investigator based on RECIST 1.1 (ORRW24).

Phase II: PFS evaluated by IRC and investigator based on RECIST.

Phase II: PFS evaluated by IRC and investigator based on iRECIST.

Phase II: Evaluate the number and percent of patients with adverse events/adverse reactions and serious adverse events/severe adverse reactions in selected patients with advanced solid tumors treated with F520 combined with lenvatinib.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)	NCT04457869	Primary Central... Secondary Centr...	F520	18 Years -	Shandong New Time Pharmaceutical Co., LTD
A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)	NCT04457869	Primary Central... Secondary Centr...	F520	18 Years -	Shandong New Time Pharmaceutical Co., LTD
A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)	NCT04457869	Primary Central... Secondary Centr...	F520	18 Years -	Shandong New Time Pharmaceutical Co., LTD
The Efficacy and Safety of F520 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).	NCT04457830	Peripheral T Ce...	F520	18 Years -	Shandong New Time Pharmaceutical Co., LTD
A Phase Ⅱ Study of F520 in Patients With Urothelial Carcinoma	NCT04636515	Locally Advance...	F520	18 Years -	Shandong New Time Pharmaceutical Co., LTD
The Efficacy and Safety of F520 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).	NCT04457830	Peripheral T Ce...	F520	18 Years -	Shandong New Time Pharmaceutical Co., LTD
Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors	NCT05740215	Solid Tumors	F520 Lenvatinib	18 Years - 75 Years	Shandong New Time Pharmaceutical Co., LTD
Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors	NCT05740215	Solid Tumors	F520 Lenvatinib	18 Years - 75 Years	Shandong New Time Pharmaceutical Co., LTD

Spots Global Cancer Trial Database for f520

Every month we try and update this database with for f520 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for f520

Every month we try and update this database with for f520 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for f520 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.