← Back to searchRecruitingRecruiting
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
NCT06613009 · Innovent Biologics (Suzhou) Co. Ltd.
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
4. Minimum life expectancy of ≥ 12 weeks;
5. Adequate organ function confirmed at screening period;
6. Histologically or cytologically confirmed unresectable,metastatic or Extensive-Stage small cell lung cancer (SCLC).
Exclusion Criteria
1. Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
2. Has adverse reactions resulting from previous anti-tumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator's discretion) prior to the first dose of the study drug;
3. Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
4. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator's discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.;
5. Women who are pregnant, have positive results in pregnancy test or are lactating;
6. Not eligible to participate in this study at the discretion of the investigator.
Study design
Enrollment target: 190 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-30
Estimated completion: 2027-08-30
Last updated: 2025-02-11
Interventions
Drug: IBI3009
Primary outcomes
- • Numbers of subjects with adverse events (Up to 3 years)
- • Number of subjects with clinically significant changes in physical examination results (Up to 3 years)
- • Number of subjects with clinically significant changes in electrocardiogram (Up to 3 years)
Sponsor
Innovent Biologics (Suzhou) Co. Ltd. · industry
Contacts & investigators
ContactLue Shen · contact · lue.shen@innoventbio.com · +86 18507159591
All locations (10)
Westmead HospitalRecruiting
Westmead, New South Wales, Australia
Wollongong HospitalNot Yet Recruiting
Wollongong, New South Wales, Australia
Austin HospitalRecruiting
Heidelberg, Victoria, Australia
The First Affiliated Hospital of Anhui Medical UniversityNot Yet Recruiting
Hefei, Anhui, China
The First Affiliated Hospital of Fujian Medical UniversityNot Yet Recruiting
Fuzhou, Fujian, China
Henan Cancer HospitalNot Yet Recruiting
Zhengzhou, Henan, China
Hunan Cancer HospitalRecruiting
Changsha, Hunan, China
The First Affiliated Hospital of Nanchang UniversityNot Yet Recruiting
Nanchang, Jiangxi, China
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)Not Yet Recruiting
Jinan, Shandong, China
Zhejiang Cancer HospitalRecruiting
Hangzhou, Zhejiang, China