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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
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Scientific title
A Phase 1, Multicenter, Open-label Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
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Secondary ID [1]
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CIBI3005A101
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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:
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: Drugs - IBI3005
Experimental: IBI3005 -
Treatment: Drugs: IBI3005
Bispecific Monoclonal Antibody-Camptothecin Derivative Conjugate for Injection (R \& D code: IBI3005)
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Intervention code [1]
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Treatment: Drugs
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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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Number of subjects with adverse events
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Assessment method [1]
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defined as any untoward medical occurrence, whether or not there is a causal relationship with the study drug, in a clinical study subject from the time informed consent form is signed
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Timepoint [1]
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up to 3 years
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Primary outcome [2]
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Number of subjects with clinically significant changes in physical examination results
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Assessment method [2]
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Clinically significant abnormal physical examination findings reported by the investigator.
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Timepoint [2]
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up to 3 years
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Primary outcome [3]
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Number of subjects with clinically significant changes in vital signs
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Assessment method [3]
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Vital signs including body temperature, pulse, respiratory rate, SpO2 and blood pressure
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Timepoint [3]
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up to 3 years
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Primary outcome [4]
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Dose limiting toxicities (DLTs)
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Assessment method [4]
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Dose limiting toxicities (DLTs) to establish MTD and/or RP2D.
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Timepoint [4]
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Up to 4 weeks
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Secondary outcome [1]
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area under the curve (AUC)
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Assessment method [1]
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area under the curve (AUC) of single and multiple doses of IBI3005
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Timepoint [1]
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up to 3 years
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Secondary outcome [2]
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maximum concentration (Cmax)
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Assessment method [2]
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maximum concentration (Cmax) of single and multiple doses of IBI3005
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Timepoint [2]
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up to 3 years
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Secondary outcome [3]
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time to maximum concentration (Tmax)
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Assessment method [3]
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time to maximum concentration (Tmax) of single and multiple doses of IBI3005
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Timepoint [3]
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up to 3 years
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Secondary outcome [4]
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clearance (CL)
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Assessment method [4]
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clearance (CL) of single and multiple doses of IBI3005
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Timepoint [4]
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up to 3 years
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Secondary outcome [5]
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apparent volume of distribution (V)
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Assessment method [5]
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apparent volume of distribution (V) of single and multiple doses of IBI3005
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Timepoint [5]
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up to 3 years
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Secondary outcome [6]
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half-life (t1/2)
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Assessment method [6]
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half-life (t1/2) of IBI3005 to the last administration of IBI3005
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Timepoint [6]
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up to 3 years
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Secondary outcome [7]
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anti-drug antibody (ADA)
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Assessment method [7]
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Incidence and characterization of anti-drug antibody (ADA).
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Timepoint [7]
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up to 3 years
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Secondary outcome [8]
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objective response rate (ORR)
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Assessment method [8]
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objective response rate (ORR) as evaluated per the RECIST v1.1 criteria.
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Timepoint [8]
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up to 3 years
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Secondary outcome [9]
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duration of response (DoR)
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Assessment method [9]
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duration of response (DoR) as evaluated per the RECIST v1.1 criteria.
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Timepoint [9]
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up to 3 years
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Secondary outcome [10]
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time to response (TTR)
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Assessment method [10]
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time to response (TTR) as evaluated per the RECIST v1.1 criteria.
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Timepoint [10]
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up to 3 years
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Secondary outcome [11]
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progression free survival (PFS)
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Assessment method [11]
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as evaluated per the RECIST v1.1 criteria.
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Timepoint [11]
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up to 3 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 tumor that is refractory to or intolerant of 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. 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.
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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
Other
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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
Not yet 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
30/06/2024
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Actual
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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
30/06/2027
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Actual
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Sample size
Target
198
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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One Clinical Research Pty Ltd - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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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
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.
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Trial website
https://clinicaltrials.gov/study/NCT06418061
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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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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 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/NCT06418061
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