NCT06976931

Study on the Safe Dosage and Therapeutic Effect of the Drug YY2201 Tablets on Patients With Advanced Cancer

A Dose-escalation Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of YY2201 in Patients With Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Jiangsu YaYao Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the safety and tolerability of YY2201 in participants with advanced solid tumors. The main questions it aims to answer are: What medical problems do participants have when taking drug YY2201? What is the maximum tolerated dose (MTD) in patients with advanced solid tumors? What is the anti-tumor efficacy of YY2201 in patients with advanced solid tumors This is a multicenter, open-label, dose-escalation phase I study. Participants will: Start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle Perform radiography tumor assessments at screening visit every 2 cycles. Keep a diary of their symptoms.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	YY2201	This is a multicenter, open-label, dose-escalation phase I study. participants will receive one single target dose of YY2201 on Cycle 0 Day 1 (C0D1) to observe safety and collect PK blood samples up to 48 h post-dose. On the third day after the first dose (Cycle 1 Day 1, C1D1), subjects will start to receive multiple doses of YY2201 orally twice daily (approximately 12 h interval) for 3 days followed by 4 days off in a 21-days treatment cycle.

Timeline

• Start date: 2025-05-26
• Primary completion: 2027-04-05
• Completion: 2027-10-11
• First posted: 2025-05-16
• Last updated: 2025-05-16

Regulatory

• FDA-regulated drug study