Actively Recruiting
A Phase 1 Multicenter, Open-label 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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of IBI3009, a monoclonal antibody-camptothecin derivative conjugate, in adults with unresectable, metastatic, or extensive-stage small cell lung cancer. This Phase 1, open-label study aims to find the maximum dose participants can tolerate and determine the recommended dose for further studies. Participants will receive IBI3009 under close medical supervision. The study includes monitoring for adverse effects and dose limiting toxicities over 28 days, with further assessments continuing up to three years. The trial collects detailed information on drug levels in the body and the body's response to treatment, alongside evaluations of tumor response and survival. During the study, participants will undergo regular physical examinations, vital sign checks, ECGs, and laboratory tests to monitor safety and treatment effects. Researchers will track adverse events and changes in health status over a period of up to three years to better understand the treatment's impact and safety profile.
CONDITIONS
Brief Title
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants able to understand and provide written informed consent
- Male or female aged 18 to 75 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1
- 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
You will not qualify if you...
- Participating in any other interventional clinical research except observational studies or follow-up phases
- Unresolved adverse reactions from previous anti-tumor therapies, except for certain low-risk conditions
- Known allergies or intolerance to IBI3009 or its components
- Major surgery within 4 weeks before first dose or planned during the study, or severe unhealed wounds
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days or until dose limiting toxicities occur
Participants receive the investigational drug IBI3009 as part of the study treatment.
Visits scheduled as per dosing and safety monitoring requirements
Duration - Up to 3 years
Participants are monitored for safety and treatment effects for up to 3 years after treatment.
Periodic visits for safety assessments and outcome evaluations
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
Research Team
L
Lue Shen
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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