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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/NCT05991349




Registration number
NCT05991349
Ethics application status
Date submitted
25/07/2023
Date registered
14/08/2023
Date last updated
12/04/2024

Titles & IDs
Public title
A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1/2 Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CIBI129A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI129

Experimental: IBI129 - IBI129


Treatment: Drugs: IBI129
Subjects will receive IBI129 on Day 1 of a 21-day cycle (or intervals determined by the Investigator and Sponsor based on safety, toxicity and PK data), until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Number of subjects with clinically significant changes in physical examination results
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Number of subjects with clinically significant changes in vital signs
Timepoint [3] 0 0
24 months
Primary outcome [4] 0 0
MTD or RP2D of IBI129
Timepoint [4] 0 0
12 months
Secondary outcome [1] 0 0
Plasma concentration (Cmax) of IBI129
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Area under the curve (AUC) of IBI129
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Time to maximum concentration (Tmax) of IBI129
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Clearance (CL) of IBI129
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Volume of distribution (V) of IBI129
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Half-life (T1/2) of IBI129
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Immunogenicity of IBI129
Timepoint [7] 0 0
12 months
Secondary outcome [8] 0 0
Objective response rate (ORR)
Timepoint [8] 0 0
24 months
Secondary outcome [9] 0 0
Duration of response (DoR)
Timepoint [9] 0 0
24 months
Secondary outcome [10] 0 0
Disease control rate (DCR)
Timepoint [10] 0 0
24 months
Secondary outcome [11] 0 0
Time to response (TTR)
Timepoint [11] 0 0
24 months
Secondary outcome [12] 0 0
Progression free survival (PFS)
Timepoint [12] 0 0
24 months
Secondary outcome [13] 0 0
Overall survival (OS)
Timepoint [13] 0 0
24 months

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. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors
(RECIST) Version 1.1.;

3. Male or female subjects = 18 years old;

4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

5. Anticipated life expectancy of = 12 weeks;

6. Adequate bone marrow and organ function
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. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor
regimens before the first administration of study drug, whichever is shorter.

3. Progressed refractory to an antibody drug conjugate that consists of an exatecan
derivative that is a topoisomerase I inhibitor.

4. Plan to receive other antitumor therapy during the study excluding palliative
radiotherapy for the purpose of symptom (like pain) relief that must also do not have
impact on tumor assessment throughout the study;

5. Known symptomatic central nervous system (CNS) metastases.

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
12/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George private Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

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 phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose
escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22~180
subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in
specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for
phase 2
Trial website
https://clinicaltrials.gov/ct2/show/NCT05991349
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
Serena Dong
Address 0 0
Country 0 0
Phone 0 0
051269566088
Fax 0 0
Email 0 0
suhua.dong@innoventbio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05991349