EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Advanced Lung Non-Small Cell CarcinomaAdvanced Malignant Solid NeoplasmNon-Small Cell Lung Cancer

Inactive Indication-

Originator Organization

Genor Biopharma Co., Ltd.

Active Organization

Genor Biopharma Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

Clinical Trials associated with GB-263

CTR20221422

/ RecruitingPhase 1/2

一项评价抗EGFR/cMET/cMET三特异性抗体GB263T在晚期非小细胞肺癌（NSCLC）和其他实体瘤患者中的安全性、耐受性、药代动力学和有效性的开放、国际多中心的I/II期临床研究

[Translation] An open, international, multicenter, Phase I/II clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the anti-EGFR/cMET/cMET trispecific antibody GB263T in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors

I期剂量递增和剂量扩展：主要目的：在晚期NSCLC和其他实体瘤受试者中评估GB263T的安全性和耐受性，探索最大耐受剂量（MTD），确定Ⅱ期推荐剂量（RP2D）；次要目的：评估GB263T的临床获益；评估GB263T在晚期NSCLC和其他实体瘤受试者中的药代动力学参数和免疫原性。 II期扩展队列研究：主要目的：评价RP2D剂量下GB263T的安全性和耐受性；评价RP2D剂量下GB263T在EGFR和/或cMET异常的晚期NSCLC受试者中的有效性次要目的：评价GB263T的其他有效性指标；评估GB263T在晚期NSCLC受试者中的药代动力学参数和免疫原性. I期和II期探索性研究目： PK和PD指标的相关性（I期）；GB263T在不同人群中的疗效预测性生物标志物。

[Translation]

Phase I dose escalation and dose expansion: Primary purpose: To evaluate the safety and tolerability of GB263T in subjects with advanced NSCLC and other solid tumors, explore the maximum tolerated dose (MTD), and determine the recommended dose for Phase II (RP2D); Secondary purpose: To evaluate the clinical benefit of GB263T; To evaluate the pharmacokinetic parameters and immunogenicity of GB263T in subjects with advanced NSCLC and other solid tumors. Phase II expansion cohort study: Primary purpose: To evaluate the safety and tolerability of GB263T at the RP2D dose; To evaluate the efficacy of GB263T at the RP2D dose in subjects with advanced NSCLC with abnormal EGFR and/or cMET Secondary purpose: To evaluate other efficacy indicators of GB263T; To evaluate the pharmacokinetic parameters and immunogenicity of GB263T in subjects with advanced NSCLC. Phase I and II exploratory study objectives: Correlation of PK and PD indicators (Phase I); Predictive biomarkers for the efficacy of GB263T in different populations.

Start Date27 Sep 2022

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

NCT05332574

/ RecruitingPhase 1/2

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.

Start Date17 May 2022

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

100 Clinical Results associated with GB-263

100 Translational Medicine associated with GB-263

100 Patents (Medical) associated with GB-263

100 Deals associated with GB-263

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 2	CN	Genor Biopharma Co., Ltd.	27 Sep 2022
Advanced Malignant Solid Neoplasm	Phase 2	CN	Genor Biopharma Co., Ltd.	27 Sep 2022
Non-Small Cell Lung Cancer	Phase 2	AU	Genor Biopharma Co., Ltd.	17 May 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05332574 (ESMO2024) Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer	15	GB263T 140-1680 mg IV weekly	(hmdetymgld) = zzcghfylwp uuqfpsqpab (ratpsbyipi ) View more	Positive	14 Sep 2024
NCT05332574 (ESMO2024) Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer	15	GB263T 140-1680 mg IV weekly (EGFR sensitive mutations and progressed after third-generation EGFR-TKI treatment)	(hmdetymgld) = gcffsnokie uuqfpsqpab (ratpsbyipi )	Positive	14 Sep 2024
NCT05332574 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	6	GB263T	(bkugvawrft) = judpdascwk gpvfnwhkaz (fbwtvifjli ) View more	Positive	26 May 2023

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