XZP-5955 / Sihuan Pharmaceutical - LARVOL DELTA

A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=360 | Recruiting | Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2021 ➔ Dec 2021

Enrollment open • Trial initiation date • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NTRK • ROS1

A Study of XZP-5955 Tablets in Patients With NTRK or ROS1 Fusion Positive Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2; N=360; Not yet recruiting; Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.

New P1/2 trial • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • NTRK • ROS1

Sihuan Pharma’s novel second-generation NTRK/ROS1 inhibitor to enter clinic in China (GBI Health) - "China’s Sihuan Pharmaceutical Holdings Group Ltd (HKEX:0460) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its in-house developed XZP-5955.The Category 1 drug is expected to become a second-generation tyrosine kinase inhibitor (TKI) targeting both NTRK and ROS1 with intellectual properties. XZP-5955 is described as having a relatively high potency against a variety of TRK and ROS1 resistant mutations including TRKA G595R, TRKA G667C, TRKC G623R, and ROS1 G2032R, and has shown dose-dependent inhibition of tumor growth, leading to significant tumor regression or even complete tumor suppression in the BaF3 LMNA-TRKA G595R xenograft model."

Non-US regulatory • Preclinical • Oncology