RecruitingPhase 1NCT06613009
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Enrollment
190 participants
Start Date
Dec 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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;
- Male or female subjects ≥ 18 years old. For Part 1, age ≥18 years and ≤75 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-1;
- Minimum life expectancy of ≥ 12 weeks;
- Adequate organ function confirmed at screening period;
- Histologically or cytologically confirmed unresectable,metastatic or Extensive-Stage small cell lung cancer (SCLC).
Exclusion Criteria6
- Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
- 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;
- Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
- 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.;
- Women who are pregnant, have positive results in pregnancy test or are lactating;
- Not eligible to participate in this study at the discretion of the investigator.
Interventions
DRUGIBI3009
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06613009
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