Clinical Study of HMPL-653 in Treatment of Advanced Malignant Solid Tumors and TGCT

NCT05277454 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2022-03-14

No results posted yet for this study

Summary

To evaluate the safety and tolerability of HMPL-653 in patients with advanced solid tumors who have failure of standard of care or can not tolerate standard of care or those with TGCT, and to determine the maximum tolerated dose (MTD) and/or the recommended phase II clinical study dose (RP2D) of HMPL-653 in patients with advanced solid tumors.

Conditions

  • Advanced Malignant Solid Tumors
  • TGCT

Interventions

DRUG

HMPL-653

Dose-escalation Stage: Several dose levels will be evaluated for HMPL-653. The participants will receive oral HMPL-653 single-dose evaluation and oral HMPL-653 QD continuously treatment in a therapeutic cycle of 28 days until reaching the criteria for the end of treatment. Dose-expansion Stage: The participants will receive HMPL-653 treatment (RP2D)until reaching the criteria for the end of treatment.

Sponsors & Collaborators

  • Hutchison Medipharma Limited

    lead INDUSTRY

Principal Investigators

  • Ying Cheng, Prof · Jilin Provincial Cancer Hospital

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
2022-01-18
Primary Completion
2024-06-28
Completion
2025-04-14

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 NCT05277454 on ClinicalTrials.gov