Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18 - 75
Trial acronym
CIBI3009A101
Clinical summary
Summary
The main purpose of this study is to evaluate how safe and tolerable a targeted therapy called IBI3009 is, and also to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 Dose (RP2D) for further testing.
Eligible participants will receive IBI3009, which is a monoclonal antibody-camptothecin derivate conjugate, as an injection.
Conditions
This trial is treating people with unresectable, metastatic or extensive-stage small cell lung cancer
Eligibility
Inclusion
- 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).
Exclusion
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
Exclusion
- You are currently being treated on a clinical trial.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Scientific Title
A Phase I Multicenter, Open-label Study of IBI3009 in Subjects With Unresectable, Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information