BPI-361175 / Betta Pharma - LARVOL DELTA

BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Xcovery Holdings, Inc. | Trial completion date: May 2027 ➔ May 2029 | Trial primary completion date: Jan 2026 ➔ Jan 2028

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A clinical review on third and fourth generation EGFR tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. (PubMed, Bioorg Med Chem) - "This review delves into the current clinical status, efficacy, safety profiles, and regulatory approvals of third-generation EGFR TKIs, including Osimertinib, Lazertinib, Furmonertinib, Aumolertinib, Rezivertinib, Befotertinib, Sunvozertinib...Notable fourth-generation candidates such as TQB3804, BPI-361175, BDTX-1535, WJ13404, QLH11811, H002, HS-10375, BBT-207, JIN-A02, and HS-10504 are highlighted for their potential to overcome the C797S mutation...By evaluating the therapeutic potential and limitations of these EGFR TKIs, this review aims to guide future research in the management of EGFR-mutant NSCLC. This acts as guiding beacon for the strategic design and development of third and fourth generation EGFR-TK inhibitors to overcome the drug resistance hurdles in the development of EGFR-TK inhibitors."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Xcovery Holding Company, LLC | Initiation date: Jul 2022 ➔ Jul 2023

Trial initiation date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BPI-361175 Tablets in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P1/2 | N=30 | Not yet recruiting | Sponsor: Xcovery Holding Company, LLC

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

BPI-361175, a 4th generation EGFR-TKI for the treatment of non-small cell lung cancer (NSCLC) (AACR 2022) - "In conclusion, BPI-361175 is a potent, selective, and orally bioavailable 4th generation EGFR-TKI which can potentially be used to treat NSCLC resistant mutations as well as at front line. Phase I clinical trial of BPI-361175 is enrolling patients in China, and US Phase I trial is expected to initiate in Q1 2022."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=90 | Recruiting | Sponsor: Betta Pharmaceuticals Co., Ltd.

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

Betta Pharmaceuticals: BPI-361175 tablets obtained clinical trial approval [Google translation] (Eastmoney.com) - "Betta Pharmaceuticals announced that the BPI-361175 tablets declared by the company for the treatment of solid tumors such as advanced non-small cell lung cancer with EGFRC797S mutations and other EGFR-related mutations have been approved by the State Food and Drug Administration. Up to now, domestic and foreign drugs targeting EGFR C797S mutations are in the preclinical or early clinical stage, and no drugs have been marketed." "

Non-US regulatory • Non Small Cell Lung Cancer • Oncology • Solid Tumor