drugset / Trial / NCT05731934

The Tolerability and Pharmacokinetics of HX301 Monolactate Capsules in Patients With Advanced Solid Tumors

NCT05731934

Phase 1 Completed 20 enrolled Hangzhou Hanx Biopharmaceuticals, Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Open label, single- and multiple-dose administration, dose-exploratory clinical phase I study to evaluate the safety, tolerability and PK profile of HX301 monolactate capsules in patients with advanced malignant solid tumors and to preliminarily evaluate its antitumor efficacy.

Timeline

Start
2020-09-15
Primary completion
2024-01-12
Completion
2024-01-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Narazaciclib Small molecule 40 mg Oral
Subject Narazaciclib Small molecule 80 mg Oral
Subject Narazaciclib Small molecule 120 mg Oral
Subject Narazaciclib Small molecule 160 mg Oral
Subject Narazaciclib Small molecule 200 mg Oral

Indications