NCT04433494

A Study of TY-302 in Patients With Advanced Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of TY-302 Capsules in Patients With Advanced Solid Tumors in China

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: TYK Medicines, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of TY-302 single and the combination with Tamoxifen in dose-escalation and dose-expansion study.The drugs involved in this study are: * TY-302 * Tamoxifen

Detailed description

This is an open-label, single-arm, phase I trial. The purpose of this study is to : * Test a safe and tolerable dose of TY-302 single and the combination with Tamoxifen * Determine the response rate of the combination * Further evaluate the safety and side effect profile for the combination of TY-302 and Tamoxifen.

Conditions

• Breast Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg	TY-302 is taken orally. Tamoxifen is taken orally.

Timeline

• Start date: 2020-12-07
• Primary completion: 2023-05-01
• Completion: 2023-12-01
• First posted: 2020-06-16
• Last updated: 2022-12-07

Locations

1 site across 1 country: China