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.

NCT06440057 · tracked via the Priya Life Science China tracker

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase

Phase 1/2

Started

2024-08-29

Last updated

2024-12-16

Condition(s) studied

Neuroendocrine Carcinoma

Investigational drug(s) / intervention(s)

ZG006

ZG006: ZG006 will be administered as an intravenous (IV) infusion.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

Objective response rate (ORR) — Up to approximately 2 years
ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.

Trial sites (1)

Facility	City	Region	Status
Chinese PLA General Hospital	Beijing	Beijing Municipality	Recruiting

More Suzhou Zelgen Biopharmaceuticals Co.,Ltd trials in China

ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

Study of ZG005 Combined With Bevacizumab Versus Sintilimab Combined With Bevacizumab in Advanced Hepatocellular Carcinoma Recruiting

ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular Starting soon

Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer Recruiting

Other trials for the same condition

ZG006 and ZG005 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

Study of ZG006 in Participants With Small Cell Lung Cancer or Neuroendocrine Carcinoma Recruiting

Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC Recruiting

A Study of ZG006 for Injection Versus Investigator-Selected Chemotherapy in Participants With Advanced Neuroendocrine Carcinoma Starting soon

A Single-arm, Open-label, Clinical Trial of Surufatinib/Serplulimab/Platinum/Etoposide in Neuroendocrine Carcinoma. Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06440057 on ClinicalTrials.gov ↗ ← All trials in China