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An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years - 75 Years |
Gender | All |
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT06157827 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 1/Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Nanjing Leads Biolabs Co.,Ltd |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
lin shen |
Principal Investigator Affiliation | Peking University Cancer Hospital & Institute |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | China |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Advanced Neuroendocrine Carcinoma |
This trial includes two parts: phase Ib and phase II study. Phase Ib is a dose-escalation and Phase II is the dose optimization and dose expansion . Phase Ib program to enroll patients with advanced neuroendocrine carcinoma (NEC) without systemic therapy.To sequentially evaluate the safety and tolerability of LBL-024 in combination with etoposide and platinum (cisplatin or carboplatin) at different doses by the dose-escalation method. Phase II includes two stages, dose optimization and dose expansion. The dose optimization part will conduct combination of LBL-024, which is a further optimization study in two dose groups, enrolling patients with EP-NEC who have not received systemic treatment, to fully assess the dose-exposure-effect relationship, and in combination with the target binding characteristics of LBL-024, pharmacokinetic/pharmacodynamic, efficacy and/or safety profile, considering multiple dimensions,To confirm the rationale for the recommended Phase 2 dose (RP2D). The recommended Phase 2 dose (RP2D) will be determined based on the safety, tolerability, efficacy and PK data from the clinical studies of LBL-024.After obtaining the RP2D, a dose expansion study of combination dosing at the RP2D will be conducted to obtain adequate efficacy data. This trial will enroll 178 patients in Phase Ib and Phase II study.
Experimental: LBL-024+Etoposide+Carboplatin/Cisplatin
LBL-024+Etoposide+Carboplatin/Cisplatin Injection,dose A、dose B or dose C; Q3W
Experimental: Atezolizumab+Etoposide+Carboplatin
Atezolizumab+Etoposide+Carboplatin Injection,dose A ; Q3W
Drug: - LBL-024 for Injection
Initial dose-MTD; Q3W; intravenous infusion
Drug: - Etoposide Injection
Initial dose(Dose was decided by the investigator according to the subject's condition); Q3W; intravenous infusion
Drug: - Carboplatin Injection
Initial dose(Dose was decided by the investigator according to the subject's condition); Q3W; intravenous infusion
Drug: - Atezolizumab injection
Initial dose; Q3W; intravenous infusion
Drug: - Cisplatin injection
Initial dose(Dose was decided by the investigator according to the subject's condition); Q3W; intravenous infusion
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Anhui Provincial Hospital
Hefei, Anhui, 230001
Status
Recruiting
Address
Anhui Cancer Hospital
Hefei, Anhui, 230031
Status
Recruiting
Address
Beijing GoBroad Hospital
Beijing, Beijing, 100070
Status
Recruiting
Address
Beijing Cancer Hospital
Beijing, Beijing, 100142
Status
Recruiting
Address
Chongqing University Cancer Hospital
Chongqing, Chongqing, 400030
Status
Recruiting
Address
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Status
Recruiting
Address
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080
Status
Recruiting
Address
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Status
Recruiting
Address
Harbin Medical University Cancer Hospital
Ha'erbin, Heilongjiang, 150081
Status
Recruiting
Address
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Status
Recruiting
Address
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Status
Recruiting
Address
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Status
Recruiting
Address
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Status
Recruiting
Address
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Status
Recruiting
Address
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801
Status
Recruiting
Address
Qilu Hospital of Shandong University
Jinan, Shandong, 250063
Status
Recruiting
Address
Shandong Cancer Hospital
Jinan, Shandong, 250117
Status
Recruiting
Address
Fudan University Shanghai Cancer Center
Shanghai, Shanghai, 200032
Status
Recruiting
Address
Shanxi Cancer hospital
Taiyuan, Shanxi, 030013
Status
Recruiting
Address
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Status
Recruiting
Address
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Status
Recruiting
Address
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Status
Recruiting
Address
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Status
Recruiting
Address
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022