H002 / Hongyun Biotech - LARVOL DELTA

Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation (clinicaltrials.gov) - P1/2 | N=76 | Recruiting | Sponsor: RedCloud Bio | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2022 ➔ Dec 2022

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

H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC (clinicaltrials.gov) - P1/2 | N=76 | Recruiting | Sponsor: RedCloud Bio

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

Phase I/IIa Study of H002 in NSCLC With Active EGFR Mutation (clinicaltrials.gov) - P1/2 | N=76 | Not yet recruiting | Sponsor: RedCloud Bio

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

NEXT-GENERATION EGFR TKI H002 FROM REDCLOUD BIO COMPLETES FIRST DOSE IN NON-SMALL CELL LUNG CANCER (PRNewswire) - "RedCloud Bio...announced completion of the first patient dosing for its next-generation EGFR TKI H002 in its H002-101CN study. The study is a multicenter phase I/IIa clinical trial in China for advanced NSCLC."

Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

H002: A wide spectrum, highly selective fourth-generation EGFR inhibitor overcoming resistance harboring C797S mutation in NSCLC (AACR 2022) - "Recently, the C797S mutation in combination with Del19 or L858R, and with T790M, has emerged as one of the most common mechanisms underlying on-target resistance to a third generation EGFR TKI, osimertinib. H002 has been demonstrated as a promising next generation EGFR inhibitor, with high selectivity, a wide spectrum and potent anti-tumor activity against various EGFR activating mutations, favorable DMPK and safety profiles. It will be further developed as a fourth-generation EGFR inhibitor to overcome drug resistance in NSCLC."

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

REDCLOUD BIO TO PRESENT PRECLINICAL DATA OF NEXT-GENERATION EGFR TKI H002 AT ANNUAL MEETING OF AMERICAN ASSOCIATION OF CANCER RESEARCH (PRNewswire) - "RedCloud Bio...announced the upcoming presentation of preclinical data of H002, a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) in non-small cell lung cancer (NSCLC). The data will be presented at the 2022 Annual Meeting of the American Association for Cancer Research (AACR), April 8-13, 2022 in New Orleans."

Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology

REDCLOUD BIO ANNOUNCES FDA ACCEPTANCE OF IND APPLICATION FOR NEXT-GENERATION EGFR INHIBITOR H002 IN NON-SMALL CELL LUNG CANCER (PRNewswire) - "RedCloud Bio...announced today that the US Food and Drug Administration (FDA) has accepted the Company's Investigational New Drug (IND) application, clearing the path to proceed Phase I/IIa clinical investigation of H002, a broad spectrum, highly selective, fourth-generation compound. The candidate will be initially evaluated for treating C797S mutation-driven resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in non-small cell lung cancer (NSCLC). H002 is the first drug candidate expected to enter clinical trials from RedCloud Bio's pipeline."

IND • Lung Cancer • Non Small Cell Lung Cancer • Oncology