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

Nanjing Leads Biolabs

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Neuroendocrine Carcinoma

Treatments: Drug: Cisplatin injection; Drug: Atezolizumab injection; Drug: Carboplatin Injection; Drug: LBL-024 for Injection; Drug: Etoposide Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06157827

LBL-024-CN002

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

LBL-024+Etoposide+Carboplatin/Cisplatin

Experimental group

Description:

LBL-024+Etoposide+Carboplatin/Cisplatin Injection，dose A、dose B or dose C; Q3W

Treatment:

Drug: Etoposide Injection

Drug: LBL-024 for Injection

Drug: Carboplatin Injection

Drug: Cisplatin injection

Atezolizumab+Etoposide+Carboplatin

Experimental group

Description:

Atezolizumab+Etoposide+Carboplatin Injection，dose A ; Q3W

Treatment:

Drug: Etoposide Injection

Drug: Carboplatin Injection

Drug: Atezolizumab injection