NCT07229898

A Phase Ⅰ Clinical Study of GEN-725 Tablets in Patients With Advanced Solid Tumors

A Phase Ⅰ Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GEN-725 Tablets in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Henan Genuine Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A phase Ⅰ clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of GEN-725 tablets in patients with advanced solid tumors.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	GEN-725 tablets	Dose-escalation part: Subjects received GEN-725 tablets at doses of 4, 6 and 8 mg. A single oral dose was administered on Cycle 1 Day 1, observation was conducted for 4 days (i.e., after oral administration of 1 GEN-725 tablet followed by a 4-day washout period), then once daily from Day 5 onward. Dosing occurred with 21 days of continuous treatment per cycle (from Day 5 to Day 25). Dose-expansion part: Subjects received GEN-725 tablets orally at a dose that depends on the outcome of dose-escalation, administered once daily for 21 consecutive days per cycle.

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

4 sites across 1 country: China