Evaluating IBI3009 for advanced 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

This study is testing a new treatment called IBI3009 to see if it's safe and how much can be given to people with advanced small cell lung cancer that can't be removed by surgery.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 10 sites (Westmead, New South Wales and 9 other locations)
• Trial ID: NCT06613009 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable, metastatic, or extensive-stage small cell lung cancer and an ECOG performance status of 0-1.

Not a fit: Patients with unresolved adverse reactions from previous anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced small cell lung cancer.

How similar studies have performed: While this approach is being explored, the specific treatment IBI3009 is novel and has not been extensively tested in similar studies.

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.

Where this trial is running

Westmead, New South Wales and 9 other locations

• Westmead Hospital — Westmead, New South Wales, Australia (Recruiting)
• Wollongong Hospital — Wollongong, New South Wales, Australia (Not_yet_recruiting)
• Austin Hospital — Heidelberg, Victoria, Australia (Recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital) — Jinan, Shandong, China (Not_yet_recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Lue Shen

Conditions Small Cell Lung Cancer