A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma

Study Purpose

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)

Recruitment Criteria

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
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Subject has voluntarily agreed to participate by giving written informed consent for the trial,and Consent to follow trial treatment and visit schedule. 2. aged 18-75 years (including borderline values) at the time of signing the informed consent form. 3. Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale. 4. Have a life expectancy of at least 12 weeks. 5. Subject has at least one measurable target lesion by RECIST 1.1 criteria. 6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.

Exclusion Criteria:

1. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period. 2. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon. 3. Systemic use of corticosteroidsor other immunosuppressants within 14 days prior to the initial use of the investigational drug;The following conditions are excluded: Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., to prevent contrast allergy) 4. Subjects with an active infection that currently requires intravenous anti infective therapy. 5. History of immunodeficiency, including positive HIV antibody test results. 6. Pregnant or lactating women. 7. The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.

Trial Details

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
Additional Details

This trial includes two parts: phase Ib and phase II study. Phase Ib is a dose-escalation phase and Phase II is a dose-expansion phase. 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 program to enroll approximately 50 patients with advanced neuroendocrine carcinoma without systemic treatment. This trial will enroll 68 patients in Phase Ib and Phase II study.

Arms & Interventions

Arms

Experimental: LBL-024+Etoposide+Cisplatin/Carboplatin

LBL-024+Etoposide+Cisplatin/Carboplatin Injection , dose A or dose B; Q3w

Interventions

Drug: - LBL-024 for Injection

Initial dose - MTD; Q3W; intravenous infusion

Drug: - Etoposide Injection

Initial dose; Q3W; intravenous infusion

Drug: - Cisplatin for Injection

Initial dose; Q3W; intravenous infusion

Drug: - Carboplatin Injection

Initial dose; Q3W; intravenous infusion

Contact a Trial Team

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.

International Sites

Anhui Cancer Hospital, Hefei, Anhui, China

Status

Recruiting

Address

Anhui Cancer Hospital

Hefei, Anhui, 230031

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Beijing Cancer Hospital, Beijing, Beijing, China

Status

Recruiting

Address

Beijing Cancer Hospital

Beijing, Beijing, 100142

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Chongqing University Cancer Hospital, Chongqing, Chongqing, China

Status

Not yet recruiting

Address

Chongqing University Cancer Hospital

Chongqing, Chongqing, 400030

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Fujian Cancer Hospital, Fuzhou, Fujian, China

Status

Recruiting

Address

Fujian Cancer Hospital

Fuzhou, Fujian, 350014

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Ha'erbin, Heilongjiang, China

Status

Recruiting

Address

Harbin Medical University Cancer Hospital

Ha'erbin, Heilongjiang, 150081

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Luoyang, Henan, China

Status

Recruiting

Address

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Henan Cancer Hospital, Zhengzhou, Henan, China

Status

Recruiting

Address

Henan Cancer Hospital

Zhengzhou, Henan, 450008

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Hubei Cancer Hospital, Wuhan, Hubei, China

Status

Not yet recruiting

Address

Hubei Cancer Hospital

Wuhan, Hubei, 430079

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Jiangsu Cancer Hospital, Nanjing, Jiangsu, China

Status

Not yet recruiting

Address

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Nanjing First Hospital, Nanjing, Jiangsu, China

Status

Not yet recruiting

Address

Nanjing First Hospital

Nanjing, Jiangsu, 210012

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Liaoning Cancer Hospital, Shenyang, Liaoning, China

Status

Not yet recruiting

Address

Liaoning Cancer Hospital

Shenyang, Liaoning, 110801

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Qilu Hospital of Shandong University, Jinan, Shandong, China

Status

Recruiting

Address

Qilu Hospital of Shandong University

Jinan, Shandong, 250063

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Shandong Cancer Hospital, Jinan, Shandong, China

Status

Recruiting

Address

Shandong Cancer Hospital

Jinan, Shandong, 250117

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai, Shanghai, 200032

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Zhongshan Hospital Fudan University, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Zhongshan Hospital Fudan University

Shanghai, Shanghai, 200032

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Shanxi Cancer hospital, Taiyuan, Shanxi, China

Status

Not yet recruiting

Address

Shanxi Cancer hospital

Taiyuan, Shanxi, 030013

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Chengdu, Sichuan, China

Status

Recruiting

Address

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Hangzhou, Zhejiang, China

Status

Not yet recruiting

Address

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Hangzhou, Zhejiang, China

Status

Recruiting

Address

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

Hangzhou, Zhejiang, China

Status

Recruiting

Address

Sir Run Run Shaw Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016

Site Contact

ling zang

zangling@leadsbiolabs.com

02583378099

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