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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
22/01/2025
Titles & IDs
Public title
Study of IBI3005 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
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Scientific title
A Multicenter, Open-label, Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI3005 in Subjects With Advanced Malignant 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:
Unresectable
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Locally Advanced 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: 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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Numbers 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
Subjects Should have been previously treated with a third-generation EGFR TKI with disease progression. Subjects with positive other driver genes or METex14 mutations are required to undergo targeted therapy and disease progression.
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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
Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study.Patients are allowed to receive inactivated vaccines.
Uncontrolled diseases including:
* Infection requiring systemic antibiotics, antivirals or antifungals within 2 weeks prior to first dose of the study drug( antiviral medication for hepatitis B and hepatitis C infection that are compliant with the protocol were allowed);
* Known human immunodeficiency virus (HIV) infection, or HIV positive (HIV 1/2 Ab positive);
* Acute or chronic active hepatitis B (HbsAg positive and/or HbcAb positive with HBV DNA titer = 104 copies/mL or = 2000 IU/mL or higher than lower limit of detection) or C (HCV Ab positive with HCV RNA titer > 103 copies/mL or higher than lower limit of detection);
* Active COVID-19 infection with obvious symptoms requiring treatment or hospitalization, such as pyrexia, dyspnea, nausea, vomiting, diarrhea, etc.;
* Active tuberculosis infection, or still on anti-tuberculosis therapy or received anti tuberculosis therapy within 1 year prior to first administration of the study drug;
* Active syphilis infection or latent syphilis requiring treatment;
* Symptomatic congestive heart failure Grade II-IV (New York Heart Association [NYHA]), symptomatic or uncontrolled arrhythmias, QTc interval > 480 ms or personal or family history of congenital long/short QT syndrome;
* Hypertension that does not receive standardized therapy or still uncontrollable hypertension (SBP = 160 mmHg or DBP = 100 mmHg); Any history of life-threatening hemorrhage, or hemorrhage requiring (including but not limited to gastrointestinal bleeding, hemoptysis, etc) blood transfusion, endoscopy, or surgery, within 3 months prior to the first administration of study drug;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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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
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
8/01/2025
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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
31/12/2027
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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)
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Shandong
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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
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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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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Yanxi Pu
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Address
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Country
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Phone
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18523197816
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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
Data sharing statement
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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