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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

Titles & IDs
Public title
Study of IBI3009 in Subjects With Unresectable, Locally Advanced or Metastatic Small Cell Lung Cancer and Other Neuroendocrine Carcinomas
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
Secondary ID [1] 0 0
CIBI3009A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer and Other Neuroendocrine Carcinomas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Neuroendocrine tumour (NET)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI3009

Experimental: IBI3009 -


Treatment: Drugs: IBI3009
Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3009)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Numbers of subjects with adverse events
Timepoint [1] 0 0
Up to 3 years
Primary outcome [2] 0 0
Number of subjects with clinically significant changes in physical examination results
Timepoint [2] 0 0
Up to 3 years
Primary outcome [3] 0 0
Number of subjects with clinically significant changes in electrocardiogram
Timepoint [3] 0 0
Up to 3 years
Primary outcome [4] 0 0
Number of subjects with clinically significant changes in vital signs
Timepoint [4] 0 0
Up to 3 years
Primary outcome [5] 0 0
Dose limiting toxicities (DLTs)
Timepoint [5] 0 0
Up to 29 days
Secondary outcome [1] 0 0
area under the curve (AUC)
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
maximum concentration (Cmax)
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
time to maximum concentration (Tmax)
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
clearance (CL)
Timepoint [4] 0 0
Up to 3 years
Secondary outcome [5] 0 0
apparent volume of distribution (V)
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
half-life (t1/2)
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
anti-drug antibody (ADA)
Timepoint [7] 0 0
Up to 3 years
Secondary outcome [8] 0 0
objective response rate (ORR)
Timepoint [8] 0 0
Up to 3 years
Secondary outcome [9] 0 0
duration of response (DoR)
Timepoint [9] 0 0
Up to 3 years
Secondary outcome [10] 0 0
time to response (TTR)
Timepoint [10] 0 0
Up to 3 years
Secondary outcome [11] 0 0
progression free survival (PFS)
Timepoint [11] 0 0
Up to 3 years
Secondary outcome [12] 0 0
overall survival (OS)
Timepoint [12] 0 0
Through out the study (an average of 3 years)

Eligibility
Key inclusion criteria
1. Subjects with 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. Anticipated life expectancy of = 12 weeks;
5. Adequate bone marrow and organ function confirmed at screening period;
6. Histologically or cytologically confirmed unresectable, locally advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine lung cancer (lung LCNEC),neuroendocrine prostate cancer (NEPC), and other extra-pulmonary neuroendocrine carcinomas;
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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) or baseline 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2027
Actual
Sample size
Target
198
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Innovent Biologics (Suzhou) Co. Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lue Shen
Address 0 0
Country 0 0
Phone 0 0
+86 18507159591
Fax 0 0
Email 0 0
lue.shen@innoventbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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