Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Study ID
- NCT06613009
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- IBI3009 — DRUGMonoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
Study Details
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.
Key Dates
- First listed
- Sep 25, 2024
- Start date
- Dec 30, 2024
- Status verified
- Feb 2025
- Primary completion
- Aug 30, 2027
- Completion
- Aug 30, 2027
Study Design
- Enrollment
- 190 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: IBI3009
Primary Outcome Measure
Numbers of subjects with adverse events [ Time Frame: Up to 3 years ]
Central Contacts
- Lue Shen+86 18507159591
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