Testing IBI3009 in adults with advanced small cell lung cancer
Tests IBI3009, a new drug, in adults with advanced small cell lung cancer.
Plain-language title generated from the registry record
Registry title: Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
Key facts
- Where
- Copenhagen Oe, Herlev, and Odense C, DenmarkSee the 3 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06613009, who can take part
Where in Denmark
- RigshospitaletCopenhagen Oe, DenmarkNo longer taking part
- Region HovedstadenHerlev, DenmarkNo longer taking part
- Odense University HospitalOdense C, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT06613009EU 2025-523972-21-00
- Record updated
- 11 February 2025
- Original description
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.Read full original descriptionShow less
A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
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.
Inclusion: 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: 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; 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; Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients; Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study; 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.