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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
Secondary ID [1] 0 0
CIBI133A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Unresectable or Metastatic Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - IBI133

Experimental: Open-label:IBI133 monotherapy -


Other interventions: 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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose limiting toxicities (DLTs)
Timepoint [1] 0 0
21 days after the first dose of IBI133
Primary outcome [2] 0 0
Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)
Timepoint [2] 0 0
Up to 90 days after the last administration
Secondary outcome [1] 0 0
maximum concentration (Cmax)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
area under the curve (AUC)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
clearance rate(CL)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
half-life (T1/2)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
anti-drug antibody (ADA)
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Preliminary efficacy including objective response rate (ORR)
Timepoint [6] 0 0
Through study completion,Up to 2 years
Secondary outcome [7] 0 0
duration of response (DoR)
Timepoint [7] 0 0
Through study completion,Up to 2 years
Secondary outcome [8] 0 0
disease control rate (DCR)
Timepoint [8] 0 0
Through study completion,Up to 2 years
Secondary outcome [9] 0 0
,time to response (TTR)
Timepoint [9] 0 0
Through study completion,Up to 2 years
Secondary outcome [10] 0 0
progression free survival (PFS)
Timepoint [10] 0 0
Through study completion,Up to 2 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;

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;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/01/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 0 0
2170 - Liverpool

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

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT06170190
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
Shijie Liu
Address 0 0
Country 0 0
Phone 0 0
+86 18701121959
Fax 0 0
Email 0 0
shijie.liu@innoventbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06170190