Evaluating IBI3009 for advanced small cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety and tolerability of IBI3009 in participants with unresectable, metastatic, or extensive-stage small cell lung cancer. It will determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of the treatment. Participants will be monitored for adverse reactions and overall health during the trial. The study is designed for individuals who meet specific eligibility criteria, including age and performance status.

Why it matters

Who can join: the full rules

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.

Where it's running

• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• Austin Hospital
  Heidelberg, Victoria, Australia Recruiting
• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting
• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting
• Wollongong Hospital
  Wollongong, New South Wales, Australia Not yet recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Not yet recruiting

Study contacts

• Study coordinator: Lue Shen
• Email: lue.shen@innoventbio.com
• Phone: +86 18507159591

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.