NCT04049929

A Phase I Study of YY-20394 in Patients With Advanced Solid Tumors

A Single-Arm, Open-Label, Multi-Center, Phase I Study of YY-20394 in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai YingLi Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Protocol YY-20394-003 is a phase I single arm, open label study. The primary objective is to assess the safety of YY-20394 in subjects with advanced solid tumor. The secondary objective is to determine the preliminary efficacy and pharmacokinetics (PK).

Detailed description

In this clinical trials, patients will be dosed YY-20394 orally at 80mg per day until disease progression, unacceptable toxicity, or withdrawal from the study. A treatment cycle is defined as 28 days. Drug safety will be evaluated by NCI-CTC AE5.0 every week within 28 days after first dose and every 2 weeks in the following cycles. Efficacy will be assessed by RECIST1.1 after 2 cycles.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	YY-20394	YY-20394 is a new type of PI3K-δ selective inhibitor which differs structurally from idelalisib and its analogs, showing high potency against PI3Kδ, but with markedly improved selectivity (\>1,000-fold selectivity for PI3K-δ versus PI3Kγ). This higher selectivity for PI3Kδ may decrease the risk of serious infection seen with idelalisib and especially with duvelisib due to strong immune suppression.Preclinical evaluation has demonstrated improved efficacy and safety for YY-20394 compared to idelalisib.

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2019-08-08
• Last updated: 2019-08-08

Locations

1 site across 1 country: China