GH2616 / Genhouse Bio - LARVOL DELTA

KIF18A inhibition and its rising role in cancer therapy trials: from bench to bedside. (PubMed, Expert Opin Investig Drugs) - "We summarize the development of small-molecule inhibitors, from early compounds like BTB-1 to second-generation agents including Sovilnesib and VLS-1488, the latter currently in Phase I/II trials...New entrants like ATX-295 and GH2616 further expand the landscape...As clinical trials progress, optimizing patient stratification and exploring synergistic combinations will be crucial. Broadening the range of druggable sites on KIF18A, especially beyond the motor domain, could mitigate resistance and help expand therapeutic potential."

Journal • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • KIF18A

GH2616C102: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GH2616 in Subjects With Advanced Solid Tumor. (clinicaltrials.gov) - P1 | N=126 | Active, not recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd.

New P1 trial • Oncology • Solid Tumor

A Dose-Escalation, Dose-Expansion Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of GH2616 Tablets in Subjects With Advanced Solid Tumors(StudyID:GH2616-101) (ChiCTR) - P1 | N=156 | Recruiting | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P1 trial • Breast Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • ALK • EGFR • ROS1 • TP53

A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor

A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=156 | Not yet recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd.

Metastases • New P1 trial • Oncology • Solid Tumor

Discovery of GH2616, a potent and selective KIF18A inhibitor with robust in vivo efficacy in p53 mutant cancer (AACR 2023) - "In conclusion, we discovered GH2616 as a novel KIF18A inhibitor with potent in vivo efficacy. It is currently under evaluation in IND-enabling studies and IND filing is expected in Q4, 2023."

Preclinical • Oncology • KIF18A