Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IBI3009 for patients with small cell lung cancer that cannot be surgically removed and has spread to other parts of the body. The main goal is to find out how safe this treatment is and to determine the highest dose that can be given without causing serious side effects. The trial is currently recruiting participants aged 18 and older, and to qualify, you must have been diagnosed with this type of lung cancer and have a life expectancy of at least 12 weeks.

If you decide to participate, you will need to give your written consent and undergo some health checks to ensure you can safely take part in the study. Throughout the trial, you will be monitored closely for any side effects from the treatment. It’s important to know that this study is specifically for those who are not currently receiving other cancer treatments and do not have severe health issues that could interfere with the study. Overall, this trial aims to provide valuable information that could help improve treatment options for people with small cell lung cancer.

Gender

ALL

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.