A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
NCT ID: NCT06157827
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
178 participants
INTERVENTIONAL
2023-12-08
2027-07-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LBL-024+Etoposide+Carboplatin/Cisplatin
LBL-024+Etoposide+Carboplatin/Cisplatin Injection，dose A、dose B or dose C; Q3W
LBL-024 for Injection
Initial dose-MTD; Q3W; intravenous infusion
Etoposide Injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Carboplatin Injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Cisplatin injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Atezolizumab+Etoposide+Carboplatin
Atezolizumab+Etoposide+Carboplatin Injection，dose A ; Q3W
Etoposide Injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Carboplatin Injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Atezolizumab injection
Initial dose; Q3W; intravenous infusion
Interventions
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LBL-024 for Injection
Initial dose-MTD; Q3W; intravenous infusion
Etoposide Injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Carboplatin Injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Atezolizumab injection
Initial dose; Q3W; intravenous infusion
Cisplatin injection
Initial dose（Dose was decided by the investigator according to the subject's condition）; Q3W; intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Nanjing Leads Biolabs Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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lin shen
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Anhui Cancer Hospital
Hefei, Anhui, China
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Cancer Hospital
Jinan, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Cancer hospital
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBL-024-CN002
Identifier Type: -
Identifier Source: org_study_id
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