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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/NCT05332574
Registration number
NCT05332574
Ethics application status
Date submitted
28/03/2022
Date registered
18/04/2022
Date last updated
5/08/2022
Titles & IDs
Public title
A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor
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Scientific title
A Phase I/II, First-in-Human, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of a Trispecific EGFR/cMET/cMET Antibody GB263T in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
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Secondary ID [1]
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GB263T-FIH001
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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:
NSCLC
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Other Solid Tumors
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - GB263T
Experimental: GB263T - Experimental: GB263T
Other interventions: GB263T
Participants will receive IV infusions of GB263T at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive GB263T at predefined dose levels and frequency, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days.
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Intervention code [1]
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Other interventions
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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 Participants With Adverse Events (AEs) and Serious AEs
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Assessment method [1]
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Timepoint [1]
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Screening up to follow-up (30 [+7] days after the last dose)
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Primary outcome [2]
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DLT in Phase I
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Assessment method [2]
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0
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Timepoint [2]
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During Cycle 1 (up to 28 days)
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Primary outcome [3]
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ORR in Phase II
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Assessment method [3]
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Timepoint [3]
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Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
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Secondary outcome [1]
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Cmax
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Assessment method [1]
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Timepoint [1]
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At predefined intervals up to 449 days
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Secondary outcome [2]
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Tmax
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Assessment method [2]
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0
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Timepoint [2]
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At predefined intervals up to 449 days
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Secondary outcome [3]
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AUC0-last
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Assessment method [3]
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0
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Timepoint [3]
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At predefined intervals up to 449 days
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Secondary outcome [4]
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AUC0-t
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Assessment method [4]
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0
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Timepoint [4]
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At predefined intervals up to 449 days
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Secondary outcome [5]
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t1/2
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Assessment method [5]
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Timepoint [5]
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At predefined intervals up to 449 days
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Secondary outcome [6]
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Cmin
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Assessment method [6]
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Timepoint [6]
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At predefined intervals up to 449 days
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Secondary outcome [7]
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Rac_Cmax
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Assessment method [7]
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0
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Timepoint [7]
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At predefined intervals up to 449 days
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Secondary outcome [8]
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Rac_AUC0-t
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Assessment method [8]
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Timepoint [8]
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At predefined intervals up to 449 days
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Secondary outcome [9]
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ADA
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Assessment method [9]
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0
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Timepoint [9]
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Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
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Secondary outcome [10]
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PFS
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Assessment method [10]
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0
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Timepoint [10]
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Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose
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Secondary outcome [11]
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DOR
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Assessment method [11]
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0
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Timepoint [11]
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Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
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Secondary outcome [12]
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CBR
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Assessment method [12]
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0
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Timepoint [12]
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Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
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Secondary outcome [13]
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OS
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Assessment method [13]
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0
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Timepoint [13]
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Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
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Eligibility
Key inclusion criteria
1. =18 years of age.
2. Subjects with histologically or cytologically confirmed metastatic or unresectable
advanced NSCLC or other solid tumors who have progressed on prior standard therapy,
have been intolerant to prior standard therapy, or have refused all other currently
available therapeutic options.
3. Subjects must have evaluable disease according to Response Evaluation Criteria in
Solid Tumors (RECIST) v1.1.
4. ECOG PS 0-1.
5. An expected survival time is =3 months.
6. Adequate organ function.
7. Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.
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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. Subjects who have had prior chemotherapy, targeted cancer therapy, immunotherapy, or
any investigational anti-cancer treatment within 2 weeks or five half-lives of the
treatment (whichever is longer), prior to the first administration of the study drug.
2. Toxicity (excluding alopecia, peripheral neuropathy, and hypothyroidism) that did not
return to class 0 or class 1 of NCI CTCAE V5.0 from prior antitumor therapy prior to
the first administration of the study drug.
3. Prior radical radiation therapy completed within 4 weeks prior to the first
administration of the study drug.
4. Subjects with untreated symptomatic brain metastases.
5. History of interstitial lung disease (ILD).
6. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures.
7. Received live virus vaccination within 30 days of first dose of study treatment.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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Other design features
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Phase
Phase 1/Phase 2
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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
17/05/2022
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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
30/06/2025
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Genesis Care - Saint Leonards
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Recruitment hospital [2]
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Westmead Hospital - Westmead
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Recruitment hospital [3]
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Cabrini Hospital Malvern - Malvern
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Recruitment hospital [4]
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St Vincent's Hospital Melbourne - Melbourne
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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3065 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genor Biopharma 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
This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid
tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D
(Phase 1), and an extension stage (Phase 2) where participants will be enrolled into
indication-specific cohorts.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05332574
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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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Shawn Yu, MD
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Address
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Country
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Phone
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021-60751991
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05332574
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