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UNKNOWNPHASE1/PHASE2

A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor

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

NCT05332574•Genor Biopharma Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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.

Locations (4)

Genesis Care

Saint Leonards, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Cabrini Hospital Malvern

Malvern, Victoria, Australia

St Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Key Dates

Start Date

May 17, 2022

Primary Completion Date

June 30, 2024

Completion Date

June 30, 2025

Last Updated

August 5, 2022

Enrollment

120

ESTIMATED participants

Conditions

NSCLCOther Solid Tumors

Interventions

GB263T

BIOLOGICAL

Contacts

Shawn Yu, MD

CONTACT

021-60751991 shawn.yu@genorbio.com

Magnetic Resonance Imaging of the Lung: Oncological Applications

NCT07486219

Lung Cancer (NSCLC)

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RECRUITINGPHASE3

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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RECRUITINGPHASE1/PHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor

Inclusion Criteria

Exclusion Criteria

Magnetic Resonance Imaging of the Lung: Oncological Applications

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements