NCT05759234

A Study of HS248 in Patients With Advanced Solid Tumors

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of HS248 in the Treatment of Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Hanhui Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a non-random, open multi-center study This study is a non-random, open multi-center phase I study, aimed at evaluation period research, aimed at In the evaluation phase study, it aims to evaluate the safety, tolerance PK characteristics and preliminary anti-tumor activity of HS248 in patients with advanced solid tumors. The study was divided into 2 phases, including dose escalation and dose expansion。

Detailed description

Main purpose: Assess the safety and tolerability of HS248 in patients with advanced solid tumors, and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of HS248. Secondary purpose: Secondary purpose: Assess the pharmacokinetic (PK) profile of HS248 in patients with advanced solid tumors; To evaluate the preliminary antitumor activity of HS248 in patients with advanced solid tumors. Preliminary antitumor activity in patients with advanced solid tumors. Other purposes: Population-based PK (PopPK) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description) analysis method, exploratory description of HS248 in patients with advanced solid tumors PK features in; Evaluate the relationship between exposure and efficacy and adverse events (AEs) of HS248 in patients with advanced solid tumors, as data permit; To explore the changes of HS248 in myeloid-derived suppressor cells (MDSC) and CD8+ T cells in patients with advanced solid tumors.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	HS248 pieces	The overall safety and tolerability of PI3Kγ inhibitor monotherapy for solid tumors is good, and it has shown preliminary clinical benefits. The safety of PI3Kγ inhibitor combined with immune checkpoint inhibitor is good, and the efficacy of single drug is significantly improved. Based on the evaluation of the safety and efficacy results of HS248 preclinical and clinical studies of similar PI3Kγ inhibitors, the benefits of this product outweigh the risks for patients with advanced solid tumors who have progressed through standard treatment, have toxicity intolerance, or have no standard treatment regimen. Sufficient to support planned clinical studies.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2023-03-08
• Last updated: 2023-03-08

Locations

1 site across 1 country: China