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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06613009
Registration number
NCT06613009
Ethics application status
Date submitted
22/09/2024
Date registered
25/09/2024
Date last updated
11/02/2025
Titles & IDs
Public title
Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
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Scientific title
A Phase 1 Multicenter, Open-label Study of IBI3009 in Participants with Unresectable, Metastatic or Extensive-Stage Small Cell Lung Cancer
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Secondary ID [1]
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CIBI3009A101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - IBI3009
Experimental: IBI3009 -
Treatment: Drugs: IBI3009
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Numbers of subjects with adverse events
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Assessment method [1]
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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
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Timepoint [1]
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Up to 3 years
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Primary outcome [2]
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Number of subjects with clinically significant changes in physical examination results
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Assessment method [2]
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Clinically significant abnormal physical examination findings reported by the investigator.
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Timepoint [2]
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Up to 3 years
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Primary outcome [3]
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Number of subjects with clinically significant changes in electrocardiogram
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Assessment method [3]
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Clinically significant abnormal electrocardiogram findings reported by the investigator.
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Timepoint [3]
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Up to 3 years
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Primary outcome [4]
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Number of subjects with clinically significant changes in vital signs
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Assessment method [4]
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Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
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Timepoint [4]
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Up to 3 years
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Primary outcome [5]
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Dose limiting toxicities (DLTs)
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Assessment method [5]
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Dose limiting toxicities (DLTs) to establish MTD and/or RDE.
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Timepoint [5]
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Up to 28 days
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Secondary outcome [1]
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area under the curve (AUC)
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Assessment method [1]
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area under the curve (AUC) of single and multiple doses of IBI3009
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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maximum concentration (Cmax)
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Assessment method [2]
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maximum concentration (Cmax) of single and multiple doses of IBI3009
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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time to maximum concentration (Tmax)
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Assessment method [3]
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time to maximum concentration (Tmax) of single and multiple doses of IBI3009
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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clearance (CL)
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Assessment method [4]
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clearance (CL) of single and multiple doses of IBI3009
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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apparent volume of distribution (V)
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Assessment method [5]
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apparent volume of distribution (V) of single and multiple doses of IBI3009
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Timepoint [5]
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Up to 3 years
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Secondary outcome [6]
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half-life (t1/2)
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Assessment method [6]
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half-life (t1/2) of IBI3009 to the last administration of IBI3009
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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anti-drug antibody (ADA)
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Assessment method [7]
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Incidence and characterization of anti-drug antibody (ADA).
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Timepoint [7]
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Up to 3 years
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Secondary outcome [8]
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objective response rate (ORR)
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Assessment method [8]
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objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
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Timepoint [8]
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Up to 3 years
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Secondary outcome [9]
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duration of response (DoR)
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Assessment method [9]
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duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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time to response (TTR)
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Assessment method [10]
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time to response (TTR) as evaluated per the RECIST v1.1 criteria.
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Timepoint [10]
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Up to 3 years
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Secondary outcome [11]
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progression free survival (PFS)
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Assessment method [11]
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as evaluated per the RECIST v1.1 criteria.
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Timepoint [11]
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Up to 3 years
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Secondary outcome [12]
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overall survival (OS)
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Assessment method [12]
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OS is defined as the time from the date of first dose of study drug until the date of death from any cause.
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Timepoint [12]
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Through out the study (an average of 3 years)
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/12/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/08/2027
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Actual
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Sample size
Target
190
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Westmead Hospital - Westmead
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Recruitment hospital [2]
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Wollongong Hospital - Wollongong
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Recruitment hospital [3]
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Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Anhui
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Country [2]
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China
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State/province [2]
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Fujian
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Country [3]
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China
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State/province [3]
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Henan
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Country [4]
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China
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State/province [4]
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Hunan
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Country [5]
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China
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State/province [5]
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Jiangxi
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Country [6]
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China
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State/province [6]
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Shandong
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Country [7]
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China
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State/province [7]
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Zhejiang
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Innovent Biologics (Suzhou) Co. Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT06613009
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lue Shen
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Address
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Country
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Phone
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+86 18507159591
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06613009
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