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

NCT07229898 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-11-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Henan Genuine Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-07
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07229898 on ClinicalTrials.gov