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

NCT04908046 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

  • Advanced Malignant Solid Tumors

Interventions

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.

Sponsors & Collaborators

  • Hutchmed

    lead INDUSTRY

Principal Investigators

  • Bin Yang · Hutchison Medipharma Limited

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2024-01-29
Completion
2024-02-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04908046 on ClinicalTrials.gov