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Trial Title:
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.
NCT ID:
NCT06440057
Condition:
Neuroendocrine Carcinoma
Conditions: Official terms:
Carcinoma
Small Cell Lung Carcinoma
Carcinoma, Neuroendocrine
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
ZG006
Description:
ZG006 will be administered as an intravenous (IV) infusion.
Arm group label:
Dose Escalation
Arm group label:
Dose Expansion
Summary:
This is a multicenter, open-label phase I/II study, divided into 2 parts:
Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of
ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are
explored. Upon completion of Part 1, investigators and the sponsor will discuss and
determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy,
and pharmacokinetic results for use in Part 2.
Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy
and safety of ZG006 in patients with Neuroendocrine Carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Fully understand the study and voluntarily sign the informed consent form;
- Male or female 18~75 years of age;
- Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
- Life expectancy ≥ 3 months.
Exclusion Criteria:
- Participants were deemed unsuitable for participating in the study by the
investigator for any reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Contact:
Last name:
Jianming Xu
Phone:
13910866712
Email:
jmxu2003@163.com
Start date:
June 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Agency class:
Industry
Source:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06440057
