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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06170190
Registration number
NCT06170190
Ethics application status
Date submitted
27/11/2023
Date registered
14/12/2023
Date last updated
6/02/2024
Titles & IDs
Public title
A Multicentre,Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
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Scientific title
A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
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Secondary ID [1]
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CIBI133A101
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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:
Locally Advanced Unresectable or Metastatic Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - IBI133
Experimental: Open-label:IBI133 monotherapy -
Treatment: Other: IBI133
IBI133:
The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the course of the study. Q3W
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Intervention code [1]
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Treatment: Other
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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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Dose limiting toxicities (DLTs)
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Assessment method [1]
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DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD)and /or recommended phase 2 dose (RP2D)
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Timepoint [1]
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21 days after the first dose of IBI133
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Primary outcome [2]
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Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)
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Assessment method [2]
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Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0
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Timepoint [2]
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Up to 90 days after the last administration
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Secondary outcome [1]
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maximum concentration (Cmax)
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Assessment method [1]
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PK parameters maximum concentration(Cmax)of IBI133,total antibody,can will be determined
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Timepoint [1]
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Up to 2 years
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Secondary outcome [2]
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area under the curve (AUC)
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Assessment method [2]
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PK parameters clearance rate of IBI133,total antibody,exate can will be determined
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Timepoint [2]
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Up to 2 years
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Secondary outcome [3]
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clearance rate(CL)
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Assessment method [3]
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PK parameters clearance rateof IBI133,total antibody,exate can will be determined
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Timepoint [3]
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Up to 2 years
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Secondary outcome [4]
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half-life (T1/2)
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Assessment method [4]
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PK parameters half-life of IBI133,total antibody,exate can will be determined
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Timepoint [4]
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Up to 2 years
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Secondary outcome [5]
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anti-drug antibody (ADA)
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Assessment method [5]
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the incidence and characterization of ADA OF IBI133 will be determined
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Timepoint [5]
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Up to 2 years
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Secondary outcome [6]
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Preliminary efficacy including objective response rate (ORR)
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Assessment method [6]
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ORR is defined as the proportion of subjects with a CR or PR. Number and percentage of subjects with CR or PR will be summarized.
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Timepoint [6]
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Through study completion,Up to 2 years
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Secondary outcome [7]
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duration of response (DoR)
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Assessment method [7]
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DoR is defined as the time from the date first achieved CR or PR until the date of first documents disease progression based on RECIST v1.1 or death
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Timepoint [7]
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Through study completion,Up to 2 years
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Secondary outcome [8]
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disease control rate (DCR)
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Assessment method [8]
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DCR is defined as the proportion of subjects with a CR, PR or SD, and will be analysed in the same fashion as ORR.
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Timepoint [8]
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Through study completion,Up to 2 years
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Secondary outcome [9]
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,time to response (TTR)
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Assessment method [9]
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TTR is defined as the time from the date of first study drug to the date first achieved CR or PR based on RECIST v1.1.
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Timepoint [9]
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Through study completion,Up to 2 years
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Secondary outcome [10]
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progression free survival (PFS)
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Assessment method [10]
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PFS is defined as the time from the date of first study drug to death or disease progression based on RECIST v1.1, whichever occurs first.
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Timepoint [10]
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Through study completion,Up to 2 years
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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;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of = 12 weeks;
5. Adequate bone marrow and organ function.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
2. Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate.
3. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Single group
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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
16/01/2024
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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
30/12/2026
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment postcode(s) [1]
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2170 - Liverpool
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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
This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).
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Trial website
https://clinicaltrials.gov/study/NCT06170190
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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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Shijie Liu
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Address
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Country
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Phone
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+86 18701121959
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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
No information has been provided regarding IPD availability
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/NCT06170190
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