Neoplasms

Digestive System Diseases

All Conditions

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Fluorouracil

Cisplatin

Immunoglobulins

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

LP002 dose escalation (3+3 design): 6-12 patients with malignant digestive system neoplasms (mainly include gastric/ gastroesophageal junction/ esophageal carcinoma) failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment will receive LP002 600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W), for up to 2 year.

If the safety profile in Arm A is acceptable, 9-12 patients with malignant gastric/ gastroesophageal junction carcinoma who are PD-L1 positive and failed (experienced progressed disease or unable to tolerate) at least two lines of previously standard treatments will receive LP002 600mg or 900 mg IV on Day 1, Q2W, for up to 2 year.

If the safety profile in Arm A is acceptable, 15-20 patients with metastatic gastric carcinoma who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W,for up to 2 year.

Perioperative treatment: If the safety profile in Arm A is acceptable, 15-20 patients with gastric or gastroesophageal junction carcinoma of cT2-4a, any N, M0 who are PD-L1 positive and systemic treatment-naive will receive LP002 900 mg IV on Day 1, Q2W, and Cisplatin 50mg/m2 IV on Day 1, Q2W, and Fluorouracil 2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W, for 3 cycles, 4-6 weeks before operation of the tumor and receive additional 6 cycles of the same therapy 4 weeks after the operation.

Dose escalation (3+3 design) of OH2 (an oncolytic virus) + LP002 900mg：If the safety profile in Arm A is acceptable, 15-30 patients with advanced solid tumors (mainly include digestive system neoplasms) who failed (experienced progressed disease or unable to tolerate) at least one line of previously standard treatment or lack of standard treatments will receive LP002 900mg IV on Day 1, Q2W, and OH2 10\^6 or 10\^7 or 10\^8 CCID50/mL by intra-tumoral injection, Q2W, for up to 2 year.

600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W).

LP002

2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W

106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W

OH2 oncolytic virus

Jing Huang, MD

Ying Liu, MD

Xinjun Liang, MD

Jingdong Zhang, MD

Peng Zhao, MD

Qingwei Zhao, M.Pharm

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 safety, pharmacokinetics and preliminary efficacy of LP002 for the treatment of malignant digestive system neoplasms will be evaluated.

A Study of LP002 for the Treatment of Patients With Malignant Digestive System Neoplasms

A Phase I Study of Safety and Pharmacokinetics of LP002 (a Humanized Monoclonal Antibody Targeting PD-L1) in Patients With Malignant Digestive System Neoplasms

Percentage of subjects achieving complete response (CR) and partial response (PR).

R0 resection rate RFS pCR

Disease Control Rate (DCR) refers to the proportion of subjects who achieve CR, PR and SD through imaging evaluation.

Duration of Response (DOR) is defined as the time from the first evidence of response (PR or CR) to the first evidence of PD or the date of death for any reason.

Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.

Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.

R0 resection rate refers to the rate of patients who have achieved curative resection of the tumor.(Curative resection refers to the absence of tumor after surgical treatment. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.)

pathological complete response rate (pCR rate) refers to the rate of patients whose tissue samples show no cancer cells left under a microscope after the anti-cancer treatment.

Taizhou HoudeAoke Biomedical Co., Ltd.

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Carboplatin

Etoposide

Etoposide phosphate

Enzyme Inhibitors

Participants recieve LP002 10 mg/kg intravenous (IV) on day 1 PLUS carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on day 1 PLUS etoposide 100 mg/m\^2 IV on days 1, 2 and 3 of each 21-day cycle

10 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.

AUC 5 administered as IV infusion on Day 1 of each 21-day cycle.

100 mg/m\^2 administered as IV infusion on Day 1, 2 and 3 of each 21-day cycle.

Jialei Wang

Huijuan Wu

Lin Wu

Xiaosheng Hang

Zhitu Zhu

Zhifang Liu

Zhigang Han

Runxiang Liang

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.

Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer

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

PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 assessed by investigators or death due to any cause, whichever occurs first.

ORR was defined as the percentage of participants who have a complete response (CR) or a partial response (PR), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

DCR was defined as the percentage of participants who have a CR or a PR or a stable disease (SD), per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

DOR was defined as the time from the first documented evidence of a response of CR or PR, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by investigators.

An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment.

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

Participants will receive LP002 10 mg/kg by intravenous (IV) infusion every 2 weeks (Q2W) for up to 24 months.

10 mg/kg administered as IV infusion on Day 1 of each 14-day cycle.

Yuankai Shi, MD

Wenyu Li

Yudan Wu, MD

Zhiming Li, MD

Ying Pang, MD

Weiping Tao, MD

Hui Zhou, MD

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.

Study of LP002 for the Treatment of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

A Multicenter, Open-Label, Single-arm Phase II Study of LP002 in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

Percentage of subjects achieving complete response (CR) and partial response (PR).

Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason. For subjects whose progression or death is unknown, PFS will be censored at the time of the last valid evaluation.

Duration of Response (DOR) is defined as the time from the first evidence of repsonse (PR or CR) to the first evidence of PD or the date of death for any reason in patients who have been confirmed to have response (2014 Lugano criteria, PR or CR).

Time to Response (TTR) refers to the time from the first treatment with the study drug to the first CR or PR on tumor evaluation.

Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause. For subjects who have not been followed up to death, OS will be censored at the last effective survival follow-up time.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of LP002 for the Treatment of Patients With Malignant Digestive System Neoplasms	NCT04755543	Digestive Syste...	LP002 Cisplatin Fluorouracil OH2 oncolytic v...	18 Years - 75 Years	Taizhou HoudeAoke Biomedical Co., Ltd.
Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer	NCT04740021	Small-cell Lung...	LP002 Carboplatin Etoposide	18 Years - 79 Years	Taizhou HoudeAoke Biomedical Co., Ltd.
Study of LP002 in Combination With Chemotherapy for Patients With Extensive Stage Small Cell Lung Cancer	NCT04740021	Small-cell Lung...	LP002 Carboplatin Etoposide	18 Years - 79 Years	Taizhou HoudeAoke Biomedical Co., Ltd.
Study of LP002 for the Treatment of Patients With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma	NCT04600947	Primary Mediast...	LP002	18 Years -	Taizhou HoudeAoke Biomedical Co., Ltd.

Spots Global Cancer Trial Database for lp002

Every month we try and update this database with for lp002 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 lp002

Every month we try and update this database with for lp002 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 lp002 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.