A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GH2616 in Subjects With Advanced Solid Tumor.

GH2616 is a potent and selective inhibitor targeting KIF18A, exhibiting distinct and superior anticancer properties compared to other cell cycle and anti-mitotic drug targets, with significant inhibitory effects on TP53 mutant and WGD (whole genome doubling) or CIN (chromosomal instability) tumors. GH2616 regulates chromosome distribution and alignment, prolongs mitotic duration, and activates the spindle assembly checkpoint by inhibiting KIF18A activity, thereby arresting mitosis at the G2/M phase, inducing mitotic catastrophe, and ultimately achieving tumor suppression. This study will evaluate the safety and tolerability of GH2616 in patients with advanced solid tumors, and determine its dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D).

NCT Number	NCT07260513
Lead Sponsor	Suzhou Genhouse Bio Co., Ltd. Collaborators: GCP ClinPlus Co., Ltd., Jiaxing Yidixi Computer Technology Co., Ltd, Nanjing CR Medicon Technology Co., Ltd., Nanjing Shihejiyin Technology, Inc., Fudan University, Peking Union Medical College Hospital
Conditions	Advanced Solid Tumor Cancer
Enrollment	126 participants
Start Date	2025-03-27
Primary Completion	2028-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-03