NCT05731934

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

A Phase I Clinical Trial of the Tolerability and Pharmacokinetics of HX301 Monolactate Capsules in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hangzhou Hanx Biopharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is divided into a screening period (28 days before first dose), treatment period, and follow-up period. In the dose escalation stage, the study will follow a 3+3 dose-escalation scheme enrolling cohorts of at least 3 subjects sequentially at escalating doses. The dose escalation phase includes a single-dose phase and a multiple-dose phase. Subjects in the single-dose phase were treated with HX301monolactate, taken orally before breakfast, and in the multiple-dose phase, the frequency of administration was once daily (QD), 3 weeks continuously, suspended for 1 week, and every 4 weeks (28 days) was a dosing cycle. Dose escalation will continue until identification of an MTD or the maximum dose is reached. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment until 28 days. Blood samples will be collected at regular intervals for pharmacokinetics (PK). The Tumor evaluation (assessed by the Investigator in accordance with Response Evaluation Criteria in Solid Tumors Version 1.1 \[RECIST 1.1\] to assess efficacy will start from the first dose and occur every 8 weeks in the first 24 weeks and every 12 weeks thereafter. After 1 year of treatment, if the sponsor and investigator determine that the subject can still benefit from treatment with HX301, the treatment may continue until the disease progresses, the investigator determines that the subject is no longer suitable for further treatment, the subject voluntarily withdraws from the treatment, or the sponsor withdraws the trial.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	HX301	At starting dose of 40 mg, followed by 4 dose levels of 80 mg, 120 mg, 160 mg, and 200 mg

Timeline

• Start date: 2020-09-15
• Primary completion: 2024-01-12
• Completion: 2024-01-12
• First posted: 2023-02-16
• Last updated: 2024-06-18

Locations

1 site across 1 country: China