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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

Titles & IDs
Public title
Study of IBI3005 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors
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
Secondary ID [1] 0 0
CIBI3005A101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable 0 0
Locally Advanced or Metastatic 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
Numbers 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
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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;

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
198
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Shandong

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Yanxi Pu
Address 0 0
Country 0 0
Phone 0 0
18523197816
Fax 0 0
Email 0 0
[email protected]
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