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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
GB263T-FIH001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NSCLC 0 0
Other Solid Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GB263T

Experimental: GB263T - Experimental: GB263T


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs) and Serious AEs
Timepoint [1] 0 0
Screening up to follow-up (30 [+7] days after the last dose)
Primary outcome [2] 0 0
DLT in Phase I
Timepoint [2] 0 0
During Cycle 1 (up to 28 days)
Primary outcome [3] 0 0
ORR in Phase II
Timepoint [3] 0 0
Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
At predefined intervals up to 449 days
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
At predefined intervals up to 449 days
Secondary outcome [3] 0 0
AUC0-last
Timepoint [3] 0 0
At predefined intervals up to 449 days
Secondary outcome [4] 0 0
AUC0-t
Timepoint [4] 0 0
At predefined intervals up to 449 days
Secondary outcome [5] 0 0
t1/2
Timepoint [5] 0 0
At predefined intervals up to 449 days
Secondary outcome [6] 0 0
Cmin
Timepoint [6] 0 0
At predefined intervals up to 449 days
Secondary outcome [7] 0 0
Rac_Cmax
Timepoint [7] 0 0
At predefined intervals up to 449 days
Secondary outcome [8] 0 0
Rac_AUC0-t
Timepoint [8] 0 0
At predefined intervals up to 449 days
Secondary outcome [9] 0 0
ADA
Timepoint [9] 0 0
Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary outcome [10] 0 0
PFS
Timepoint [10] 0 0
Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose
Secondary outcome [11] 0 0
DOR
Timepoint [11] 0 0
Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary outcome [12] 0 0
CBR
Timepoint [12] 0 0
Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary outcome [13] 0 0
OS
Timepoint [13] 0 0
Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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
Single group
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
17/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Genesis Care - Saint Leonards
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3144 - Malvern
Recruitment postcode(s) [4] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genor Biopharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05332574
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
Shawn Yu, MD
Address 0 0
Country 0 0
Phone 0 0
021-60751991
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05332574