NCT04908046

A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors

Study Title A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-295S1 in Treatment of the Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety, tolerability and PK profile of HMPL-295S1 and determine MTD and/or RP2D in patients with advanced malignant solid tumor. It will be extended to enroll 10-15 patients at this dose after RP2D is determined, as to further evaluate the safety of RP2D and the preliminary efficacy of HMPL-295S1. In addition, an exploratory study on the pharmacokinetic biomarkers of HMPL-295S1 is planned in this study.

Detailed description

This study is expected to enroll 52-87 patients, including 30-60 patients for dose escalation, the enrollment will continue until about 12 patients in the dose group with response, as to determine RP2D (assuming the two dose groups will continue enrollment to 12 patients), additional 10-15 patients will be enrolled at the dose level of determined RP2D. The number of patients finally screened in the study will depend on the number of dose levels evaluated, occurrence of dose-limiting toxicity (DLT) in each dose group and the failure rate of screening.

Conditions

• Advanced Malignant Solid Tumors

Interventions

Type	Name	Description
DRUG	HMPL-295S1 with dose escalation stage of 5mg up to 200mg, then expansion stage with recommended dose of therapeutic cycle of 28 days .	Patient starts the initial dose treatment with 5mg QD of HMPL-295S1, during dose escalation, single-dose PK evaluation will be carried out firstly in each dose group. At the first therapeutic dose level, the single-dose treatment period is 5 days; from the 2nd dose level, the sponsor can determine the adjustment of single-dose treatment period to 3-5 days based on the available PK profile. Subsequently, the patients will receive oral HMPL-295S1 QD continuously in a therapeutic cycle of 28 days (Day 1 - 28 of each cycle), until reaching the criteria on the end of treatment. The patients in RP2D extended cohort will enter the consecutive treatment period directly.

Timeline

• Start date: 2021-05-27
• Primary completion: 2024-01-29
• Completion: 2024-02-23
• First posted: 2021-06-01
• Last updated: 2024-10-15

Locations

1 site across 1 country: China