IBI3009: Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Numbers of subjects with adverse events — Up to 3 years defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
Number of subjects with clinically significant changes in physical examination results — Up to 3 years Clinically significant abnormal physical examination findings reported by the investigator.
Number of subjects with clinically significant changes in electrocardiogram — Up to 3 years Clinically significant abnormal electrocardiogram findings reported by the investigator.
Number of subjects with clinically significant changes in vital signs — Up to 3 years Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
Dose limiting toxicities (DLTs) — Up to 28 days Dose limiting toxicities (DLTs) to establish MTD and/or RDE.
Trial sites (10)
Facility
City
Region
Status
Westmead Hospital
Westmead
New South Wales
Recruiting
Wollongong Hospital
Wollongong
New South Wales
Not Yet Recruiting
Austin Hospital
Heidelberg
Victoria
Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Not Yet Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangxi
Not Yet Recruiting
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
Jinan
Shandong
Not Yet Recruiting
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
Recruiting
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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