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Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of SYHA1801 Monotherapy in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:
A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Anti-tumor Activity of SYHA1801 Capsules in Patients With Advanced Solid Tumors.

Clinical Trial Summary

This is a safety, pharmacokinetic and pharmacodynamic study designed to estimate the maximum tolerated dose (MTD), and determine the Recommended Phase 2 Dose (RP2D) of SYHA1801, a BRD4 inhibitor in patients with advanced solid tumors.

Clinical Trial Description

This study will be performed in two parts. Part 1 will enroll patients with advanced solid tumors. Patients will receive SYHA1801 orally on Days 1 and 4-31 in the first cycle. Enrollment will follow a dose-escalation schedule until grade 3 drug-related adverse events are observed, at this point the i3+3 enrollment design will be used. Dose increments will be guided by data generated from previous levels. The dose and possibly the schedule will be adjusted to determine the Maximum Tolerated Dose (MTD). If a patient wishes to continuously receive study treatment on completion of Cycle 1, the patient can continue study treatment in 28-day Cycle 2 and subsequent cycles.

Part 2 will enroll patients with specific solid tumor which might potentially respond to BRD4 inhibitor. Patients will receive SYHA1801 at a dose and schedule established in Part 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04309968
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact
Status Recruiting
Phase Phase 1
Start date April 7, 2020
Completion date June 30, 2023
View Details
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