NCT07260513

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Suzhou Genhouse Bio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Advanced Solid Tumor Cancer

Interventions

Type	Name	Description
DRUG	GH2616 Tablets for oral administration at specified doses on scheduled days.	Drug: GH2616 Treatment group: Subjects will receive GH2616 orally in a dose escalation until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the study.

Timeline

• Start date: 2025-03-27
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

2 sites across 1 country: China