Status:
RECRUITING
A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma
Lead Sponsor:
Nanjing Leads Biolabs Co.,Ltd
Conditions:
Advanced Neuroendocrine Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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 neuroend...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Subject has voluntarily agreed to participate by giving written informed consent for the trial，and Consent to follow trial treatment and visit schedule
- aged 18-75 years (including borderline values) at the time of signing the informed consent form
- Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
- Have a life expectancy of at least 12 weeks
- Subject has at least one measurable target lesion by RECIST 1.1 criteria
- 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
- 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
- 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
- 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)
- Subjects with an active infection that currently requires intravenous anti infective therapy
- History of immunodeficiency, including positive HIV antibody test results
- Pregnant or lactating women
- 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.
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2027
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT06157827
Start Date
December 8 2023
End Date
July 20 2027
Last Update
January 2 2026
Active Locations (24)
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1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
Anhui Cancer Hospital
Hefei, Anhui, China, 230031
3
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 100070
4
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142