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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06418061




Registration number
NCT06418061
Ethics application status
Date submitted
6/05/2024
Date registered
16/05/2024
Date last updated
16/05/2024

Titles & IDs
Public title
Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1, Multicenter, Open-label Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
CIBI3005A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IBI3005

Experimental: IBI3005 -


Treatment: Drugs: IBI3005
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
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
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 vital signs
Timepoint [3] 0 0
up to 3 years
Primary outcome [4] 0 0
Dose limiting toxicities (DLTs)
Timepoint [4] 0 0
Up to 4 weeks
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

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 tumor that is refractory to or intolerant of 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. Enrolled in any other interventional clinical research unless only involved in an observational study (non-interventional) 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 investigators' opinion) prior to first administration of the study drug;
3. Multiple concurrent malignant tumors within 5 years: except adequately resected non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured;
4. Allergic or hypersensitive to other monoclonal antibodies and/or exatecan or other camptothecin-derived agents (e.g., topotecan) based therapy, or any ingredients of IBI3005;
5. 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
30/06/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
198
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
One Clinical Research Pty Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

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

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of IBI3005 and to determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI3005.
Trial website
https://clinicaltrials.gov/study/NCT06418061
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06418061