NSCLCPhase 1/2NCT05332574
A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor
A Phase 1/2 study testing GB263T in people with NSCLC and Other Solid Tumors, run by Genor Biopharma Co., Ltd. at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC, Other Solid Tumors
- What is being tested?
- GB263T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesAustralia
- Study dates
- 17 May 2022to 30 Jun 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age.
- 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.
- Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- ECOG PS 0-1.
- An expected survival time is ≥3 months.
- Adequate organ function.
- Subjects in Phase II must agree to provide pre-treatment tumor tissue samples.
Who cannot join
- 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.
- 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.
- Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
- Subjects with untreated symptomatic brain metastases.
- History of interstitial lung disease (ILD).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
- Received live virus vaccination within 30 days of first dose of study treatment.
Trial locations and contacts
4 sites in 1 country.
Australia4 sites, 4 recruiting
- Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, 3144
- Recruiting
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065
- Recruiting
Genesis Care
Saint Leonards, New South Wales, 2065
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
About this study
Official 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
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.
- Conditions
- NSCLC, Other Solid Tumors
- Being tested
- GB263T
- Keywords
- NSCLC, Phase 1/2, GB263T, EGFR/cMET/cMET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB263TBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| GB263T | Experimental | Experimental: GB263T Receives: Biological: GB263T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious AEs
Measured: Screening up to follow-up (30 [+7] days after the last dose)
DLT in Phase I
Measured: During Cycle 1 (up to 28 days)
ORR in Phase II
Measured: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Secondary outcomes (13)
Cmax
Measured: At predefined intervals up to 449 days
Tmax
Measured: At predefined intervals up to 449 days
AUC0-last
Measured: At predefined intervals up to 449 days
AUC0-τ
Measured: At predefined intervals up to 449 days
t1/2
Measured: At predefined intervals up to 449 days
Cmin
Measured: At predefined intervals up to 449 days
Rac_Cmax
Measured: At predefined intervals up to 449 days
Rac_AUC0-τ
Measured: At predefined intervals up to 449 days
ADA
Measured: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
PFS
Measured: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose
DOR
Measured: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
CBR
Measured: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
OS
Measured: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start17 May 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332574
- Sponsor's protocol ID
- GB263T-FIH001
- Status last verified
- Mar 2022
- First submitted
- 28 Mar 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05332574
- Acronym / sponsor ID
- GB263T-FIH001
- Conditions
- NSCLC, Other Solid Tumors
- Keywords
- NSCLC, Phase 1/2, GB263T, EGFR/cMET/cMET
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB263T | Experimental | Biological: GB263TExperimental: GB263T |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years of age.
- 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.
- Subjects must have evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- ECOG PS 0-1.
- An expected survival time is ≥3 months.
Key exclusion criteria (7 listed)
- 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.
- 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.
- Prior radical radiation therapy completed within 4 weeks prior to the first administration of the study drug.
- Subjects with untreated symptomatic brain metastases.
- History of interstitial lung disease (ILD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB263TParticipants 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. | Biological | GB263T |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (30 [+7] days after the last dose)
DLT in Phase I
Time frame: During Cycle 1 (up to 28 days)
ORR in Phase II
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
13 secondary outcomes
Cmax
Time frame: At predefined intervals up to 449 days
Tmax
Time frame: At predefined intervals up to 449 days
AUC0-last
Time frame: At predefined intervals up to 449 days
AUC0-τ
Time frame: At predefined intervals up to 449 days
t1/2
Time frame: At predefined intervals up to 449 days
Cmin
Time frame: At predefined intervals up to 449 days
Rac_Cmax
Time frame: At predefined intervals up to 449 days
Rac_AUC0-τ
Time frame: At predefined intervals up to 449 days
ADA
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
PFS
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose
DOR
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
CBR
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
OS
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GB263T in people with NSCLC and Other Solid Tumors, run by Genor Biopharma Co., Ltd. at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn Yu, MD (021-60751991, shawn.yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious AEs (time frame: Screening up to follow-up (30 [+7] days after the last dose)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.