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New treatment option for Small Cell Lung Cancer
Official title Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06613009
What this study is testing
What is IBI3009?
IBI3009 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants have the ability to understand and give written informed consent for participation in this trial, including all evaluations and...
- Male or female people ≥ 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;
You likely can't join if
- Participating in any other treatment clinical research except observational (non-treatment) study or in the follow-up phase of an treatment 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...
- 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)...
- 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.
See the full eligibility criteria
- 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 people ≥ 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).
- Participating in any other treatment clinical research except observational (non-treatment) study or in the follow-up phase of an treatment 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Westmead, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Heidelberg, Victoria, Australia
- Hefei, Anhui, China
- Fuzhou, Fujian, China
- Zhengzhou, Henan, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Westmead, New South Wales, Australia; Wollongong, New South Wales, Australia; Heidelberg, Victoria, Australia; Hefei, Anhui, China; Fuzhou, Fujian, China; Zhengzhou, Henan, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.