Not currently recruiting at UC Irvine

HMPL-A580 in Participants With Advanced or Metastatic Solid Tumor

a study on Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Zhaohui Arter

Description

Summary

This is a first-in-human, multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A580 in participants with unresectable, advanced or metastatic solid tumors.

Official Title

A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A580 in Participants With Advanced or Metastatic Solid Tumors

Details

To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of HMPL-A580 in solid tumors.

To characterize the safety, tolerability, and preliminary efficacy of HMPL-A580 at RDE(s) to determine recommended dose(s) for phase 2 dose (RP2D) or phase 3 dose (RP3D) in participants with selected solid tumors.

Keywords

Solid Tumors, Adult, HMPL-A580

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Understood this study and are able to voluntarily sign the informed consent form (ICF);
  2. Male or Female, Age ≥ 18 years;
  3. Histological confirmed, unresectable, advanced or metastatic solid tumor
  4. Participants must have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1
  5. Life expectancy ≥ 12 weeks
  6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1

You CAN'T join if...

  1. An established diagnosis of type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
  2. Use strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug
  3. Major surgery within 28 days prior to the first dose of study drug
  4. Active infection requiring systemic treatment
  5. Participant has received a live within 3 months before study enrollment
  6. History of inflammatory gastrointestinal diseases
  7. Known hypersensitivity to any component of HMPL-A580
  8. Pregnant (positive pregnancy test) or lactating;

Locations

  • University of California Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • University of Washington/Fred Hutchinson Cancer Center not yet accepting patients
    Seattle Washington 98109 United States
  • Emory Winship Cancer Institute accepting new patients
    Atlanta Georgia 30322 United States
  • BRCR Global accepting new patients
    Plantation Florida 33324 United States
  • Florida Clinical Trials Group LLC (Plantation) accepting new patients
    Plantation Florida 33324 United States
  • Florida Clinical Trials Group LLC (Tamarac) accepting new patients
    Tamarac Florida 33319 United States

Lead Scientist at UC Irvine

  • Zhaohui Arter
    Assistant Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 42 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Hutchmed
ID
NCT07396584
Phase
Phase 1/2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 186 study participants
Last Updated