Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06613009

Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-02-11

190

Participants Needed

10

Research Sites

139 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main purpose of this study is to evaluate the safety and tolerability of IBI3009 and to determine the maximum tolerated dose (MTD) and/or the recommended dose for expansion (RDE) of IBI3009.

CONDITIONS

Official Title

Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and provide written informed consent for study participation
  • Male or female aged 18 to 75 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
  • Minimum life expectancy of at least 12 weeks
  • Adequate organ function confirmed at screening
  • Histologically or cytologically confirmed unresectable, metastatic, or extensive-stage small cell lung cancer
Not Eligible

You will not qualify if you...

  • Participation in other interventional clinical research except observational studies or follow-up phases
  • Unresolved adverse reactions from previous anti-tumor therapies above Grade 1 toxicity (except certain conditions like alopecia and fatigue)
  • Known allergies or intolerance to IBI3009 or its ingredients
  • Major surgery within 4 weeks before first dose or expected during study, or severe unhealed wounds or trauma
  • Pregnant or lactating women or positive pregnancy test
  • Deemed ineligible by the investigator for any reason

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Actively Recruiting

2

Wollongong Hospital

Wollongong, New South Wales, Australia, 2500

Not Yet Recruiting

3

Austin Hospital

Heidelberg, Victoria, Australia, 3084

Actively Recruiting

4

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230022

Not Yet Recruiting

5

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350005

Not Yet Recruiting

6

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

Not Yet Recruiting

7

Hunan Cancer Hospital

Changsha, Hunan, China, 410000

Actively Recruiting

8

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

Not Yet Recruiting

9

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan, Shandong, China, 250117

Not Yet Recruiting

10

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310005

Actively Recruiting

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Research Team

L

Lue Shen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer | DecenTrialz