GB263T / Walvax - LARVOL DELTA

2024 ESMO: Jiahe Biotech’s GB263T demonstrates clinical effectiveness and safety results [Google translation] (GenorBio Press Release) - P1/2 | N=120 | NCT05332574 | Sponsor: Genor Biopharma Co., Ltd. | "GB263T shows promising efficacy at therapeutic doses (1260-1680 mg). The objective response rate (ORR) at the effective therapeutic dose for patients with EGFR-sensitizing mutations and resistant to third-generation TKI therapy was 6%; Clear benefit was observed in 3 patients with cMET changes who had failed treatment with third-generation EGFR-TKI. Advantageous security features are also shown. Infusion-related reactions occurred less frequently (33%) and were mild in severity; Paronychia and rash were mild (grade 1/2), and diarrhea was only grade 1; No MET target-related peripheral edema toxicity occurred."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Updated results from a first-in-human, phase I/II study of GB263T, a novel EGFR/cMET/cMET tri-specific antibody, in patients with advanced EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) (ESMO 2024) - P1/2 | "GB263T showed a favorable safety profile with promising efficacy at the therapeutic dose (1260-1680mg) in previously heavily treated patients with EGFRm NSCLC."

Clinical • Metastases • P1/2 data • Trispecific • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3

Dose escalation results from a first-in-human, phase I/II study of GB263T, a novel EGFR/cMET/cMET trispecific antibody, in patients with advanced EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). (AACR-NCI-EORTC 2023) - No abstract available

Clinical • Metastases • P1/2 data • Trispecific • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Preliminary dose escalation results from a first-in-human, phase I/II study of GB263T, a novel EGFR/cMET/cMET trispecific antibody, in patients with advanced EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). (ASCO 2023) - P1/2 | "Results to date demonstrate a favorable safety profile with early signal of clinical activity. Continued dose escalation and clinical investigation of GB263T is ongoing. Updated data will be presented."

Clinical • Metastases • P1/2 data • Trispecific • Fatigue • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor (clinicaltrials.gov) - P1/2 | N=120 | Recruiting | Sponsor: Genor Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Safety, Tolerability, PK and Preliminary Activity Study of GB263T in Advanced NSCLC and Other Solid Tumor (clinicaltrials.gov) - P1/2 | N=120 | Not yet recruiting | Sponsor: Genor Biopharma Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Characterization of GB263T, a tri-specific antibody against EGFR/cMET/cMET for NSCLC (AACR 2022) - "Amivantamab, a bispecific antibody to EGFR/c-Met has shown that concurrent inhibition of EGFR and c-Met can overcome resistance of EGFR-TKIs and improve patient outcomes. GB263T is a novel tri-specific antibody that exhibited robust anti-tumor activity. The preclinical data indicate that GB263T has great potential to become an effective therapeutics in the treatment of NSCLC."

Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • FCGR3A