NCT06225856

An Open-Label, Multicenter, Phase I Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of YY201 in Patients With Advanced Solid Tumors and Hematological Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Shanghai Yuyao Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase I clinical study of YY201 in the patients with relapsed/refractory lymphomas and relapsed/refractory large granular lymphocytic leukemia who failed or cannot tolerate standard treatment.

Detailed description

This study includes a dose escalation phase and a dose expansion phase. In the dose escalation phase the MTD and/or RP2D of YY201 will be determined and in the dose expansion phase the anti-tumor efficacy of YY201 will be evaluated in patients with relapsed⁄refractory hematological malignancies. The two-phase study will assess the preliminary anti-tumor efficacy , safety, tolerability, and PK profile of YY201 .

Conditions

• Advanced Solid Tumor
• Hematological Malignancy

Interventions

Type	Name	Description
DRUG	YY201	Oral administration under fasting state.

Timeline

• Start date: 2023-10-26
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2024-01-26
• Last updated: 2024-01-31

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study