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

Recruiting now · Phase 1

Conditions studied: Small Cell Lung Cancer

In brief

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 facts

Study ID

NCT06613009

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

190

Starts

2024-12-30

Expected to finish

2027-08-30

Last updated by the study team

2025-02-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Participating in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of an interventional study;
• 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;
• Known allergies, hypersensitivity, or intolerance to IBI3009 or its excipients;
• 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.;
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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