CG001419 / GNI Group - LARVOL DELTA

A Phase 1 Study of CG001419 Administered Orally in Healthy Subjects (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Cullgen Australia Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

A Phase 1 Study of CG001419 Administered Orally in Healthy Subjects (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Cullgen Australia Pty Ltd

New P1 trial • Pain

Cullgen Announces First-In-Human Dose in Phase I/II Trial of CG001419, a First-in-Class TRK Protein Degrader for Treatment of Cancer Patients (Businesswire) - "Cullgen...announced that it has initiated dosing with its orally bioavailable pan-TRK degrader, CG001419, in a Phase I/II clinical trial for patients with solid tumors. CG001419 is a potential first-in-class, highly active small molecule developed to selectively degrade both mutant and wild-type TRK proteins....The first-in-human trial of CG001419 is a Phase I/II trial with adaptive design. The Phase Ia portion of the trial is an open label, non-randomized, dose escalation study to evaluate the safety, tolerability, PK profile, and preliminary efficacy of CG001419 in patients with advanced or metastatic solid tumors....Patients that complete the Phase Ia trial may transition into the Phase Ib or Phase II portions of the trial depending on safety and tolerability results, the patient’s NTRK aberration type, and the judgment of physicians."

Trial status • Oncology • Solid Tumor

Cullgen Announces Chinese NMPA Allowance of Investigational New Drug Application of TRK Degrader to Begin Clinical Trials (Businesswire) - "Cullgen...announced that the Chinese National Medical Products Administration (NMPA) has allowed the Investigational New Drug (IND) application for CG001419, a TRK degrader for the treatment of solid tumors. CG001419 is a first-in-class, selective, potent oral targeted protein degrader for the treatment of neurotrophic tyrosine receptor kinase (NTRK) fusion-positive cancers, which have been identified in numerous solid tumors including non-small cell lung, breast, and pancreatic cancers. Cullgen will commence a Phase I clinical trial program in humans for CG001419 in China promptly."

New P1 trial • Breast Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Thoracic Cancer • NTRK