LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the efficacy and safety of LP002 for the treatment of relapsed or refractory primary mediastinal large B-cell lymphoma will be evaluated.

Start Date30 Dec 2020

Sponsor / Collaborator

Taizhou Houde Aoke Technology Co. Ltd.

NCT04740021 / Unknown statusPhase 2

A Single-arm, Open-lable, Multicenter, Phase II Clinical Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer

LP002 is a highly selected recombinant humanized anti-PD-L1 monoclonal antibody. This is a single-arm, multicenter study to evaluate the efficacy and safety of LP002 in combination with chemotherapy in patients with extensive stage samll cell lung cancer.

Start Date02 Dec 2020

Sponsor / Collaborator

Taizhou Houde Aoke Technology Co. Ltd.

CTR20201477 / RecruitingPhase 2

重组人源化抗PD-L1单克隆抗体LP002注射液联合化疗一线治疗广泛期小细胞肺癌的II期临床研究

[Translation] Phase II clinical study of recombinant humanized anti-PD-L1 monoclonal antibody LP002 injection combined with chemotherapy as first-line treatment for extensive-stage small cell lung cancer

LP002联合依托泊苷和卡铂治疗广泛期小细胞肺癌的无进展生存期（PFS）

[Translation]

Progression-free survival (PFS) of LP002 combined with etoposide and carboplatin in the treatment of extensive-stage small cell lung cancer

Start Date13 Oct 2020

Sponsor / Collaborator

Taizhou Houde Aoke Technology Co. Ltd.

100 Clinical Results associated with Recombinant humanized PD-L1 monoclonal antibody(Taizhou HoudeAoke Biomedical Co., Ltd.)

100 Translational Medicine associated with Recombinant humanized PD-L1 monoclonal antibody(Taizhou HoudeAoke Biomedical Co., Ltd.)

100 Patents (Medical) associated with Recombinant humanized PD-L1 monoclonal antibody(Taizhou HoudeAoke Biomedical Co., Ltd.)

Literatures (Medical) associated with Recombinant humanized PD-L1 monoclonal antibody(Taizhou HoudeAoke Biomedical Co., Ltd.)

23 Oct 2024·Zhonghua zhong liu za zhi [Chinese journal of oncology]

[Clinical predictive value of PD-1/PD-L1-induced electrocardiogram changes for cardiotoxicity].

Article

Author: Li, X J ; Peng, L L ; Xue, N ; Wu, D W

Objective: To observe the electrocardiogram (ECG) changes of programmed death receptor 1 (PD-1)/programmed death receptor-ligand 1 (PD-L1) immune checkpoint inhibitors before and after immunotherapy of patients during clinical antitumor process, and to explore the occurrence and influencing factors of cardiotoxicity of immune checkpoint inhibitors. Methods: A total of 93 patients with locally advanced or metastatic solid tumors confirmed by pathological diagnosis in Cancer Hospital of Chinese Academy of Medical Sciences from October 1, 2019 to September 30, 2020 were selected and treated with PD-1/PD-L1 inhibitor monotherapy. Groups were divided according to immunotherapy regimen: Group A (drug code: 609A), 16 patients were given 1 mg/kg of the drug for 21 days; Group B (drug code: HX008), 23 patients were treated with 200mg for 21 days; Group C (drug code: GB226), 28 patients were treated with 3mg/kg for 14 days; Group D (drug code: LP002), 26 patients were treated with 900mg for 14 days. The patients were monitored and followed up for 10 cycles. The ECG results of each group were recorded, and the correlation between ECG abnormality and cardiotoxicity was analyzed. Results: A total of 75 patients showed abnormal ECG that met the diagnostic criteria. There was no significant difference in abnormal ECG rate after immunotherapy in group A (P＞0.05), while the incidence of adverse cardiac events increased after immunotherapy in group B (P＜0.05), and the abnormal ECG rate increased significantly after chemotherapy in group C and group D. There was statistical difference before and after immunotherapy (P＜0.001). The number of abnormal cases in group A (8 cases, 50.0%, 8/16) was significantly lower than that of group B (20 cases, 87.0%, 20/23). The number of abnormal cases in group C and group D was 24 (85.7%) and 23 (88.4%), respectively, without statistical difference (P＞0.05), but their abnormal rates of ECG were higher than that in group A. The incidence of electrical adverse events in immunotherapy center of patients with underlying diseases was 1.93 times higher than that of patients without underlying diseases. The incidence of central electrical adverse events during immunotherapy in group B, C and D was 6.667, 6.000 and 7.667 times higher than that in group A, respectively. Conclusions: The high sensitivity of early ECG changes induced by immune checkpoint inhibitors enables early prediction of related cardiotoxicity. The presence or absence of comorbid underlying disease and drug dosage are correlated with the occurrence of adverse cardiac events, and these early changes provide a evidence for clinical treatment and prevention.

100 Deals associated with Recombinant humanized PD-L1 monoclonal antibody(Taizhou HoudeAoke Biomedical Co., Ltd.)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	Phase 2	CN	Taizhou Houde Aoke Technology Co. Ltd.	13 Oct 2020
Cutaneous Squamous Cell Carcinoma	Phase 2	CN	Taizhou Houde Aoke Technology Co. Ltd.	22 Oct 2019
Digestive System Neoplasms	Phase 1	CN	Taizhou Houde Aoke Technology Co. Ltd.	12 Jun 2019
Advanced Malignant Solid Neoplasm	Phase 1	CN	Taizhou Houde Aoke Technology Co. Ltd.	23 Nov 2018
Primary mediastinal large B-cell lymphoma recurrent	Discovery	CN	Taizhou Houde Aoke Technology Co. Ltd.	30 Dec 2020
Locally Advanced Melanoma	Discovery	CN	Taizhou Houde Aoke Technology Co. Ltd.	20 Aug 2020
Squamous Cell Carcinoma	Discovery	CN	Lepu Biopharma Co., Ltd.	29 Jun 2018

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