Not currently recruiting at University of California Health

HMPL-A830 in Solid Tumors

a study on Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

Description

Summary

This is a first-in-human (FIH), multicenter, open-label, phase I/Ⅱa clinical study of HMPL-A830 in participants with histologically or cytologically confirmed, unresectable, advanced, or metastatic solid tumors*, who are refractory or progressed on/after available standard treatment. The study will be conducted in 2 parts:

Dose Escalation (Part A, Phase I), approximately 57 participants will be enrolled.

Dose Optimization (Part B, Phase IIa), approximately 90 participants will be enrolled.

Official Title

A Phase I/Ⅱa Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of HMPL-A830 in Solid Tumors

Details

Part A: To evaluate the safety, tolerability, and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for optimization (RDO) of HMPL-A830 in previously treated participants with solid tumors.

Part B: To characterize the safety, tolerability, and preliminary efficacy of HMPL-A830 at RDO(s) to determine recommended dose(s) for phase 2 (RP2D) or phase 3 (RP3D) in participants with selected solid tumors

Keywords

Solid Tumor, Adult, HMPL-A830

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. 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
  2. Major surgery within 28 days prior to the first dose of study drug
  3. Active infection requiring systemic treatment
  4. History of inflammatory gastrointestinal diseases
  5. Known hypersensitivity to any component of HMPL-A830
  6. Pregnant (positive pregnancy test) or lactating;

Locations

  • University of California Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • START Mountain Region not yet accepting patients
    West Valley City Utah 84119 United States
  • Beijing Cancer Hospital accepting new patients
    Beijing China
  • Jilin Cancer Hospital not yet accepting patients
    Changchun China
  • Hunan Cancer Hospital not yet accepting patients
    Changsha China
  • West China Hospital of Sichuan University not yet accepting patients
    Chengdu China
  • The Sixth Affiliated Hospital,Sun Yat-sen University accepting new patients
    Guangzhou China
  • Shandong Cancer Hospital accepting new patients
    Jinan China
  • Jiangsu Province Hospital accepting new patients
    Nanjing China
  • Shanxi Provincial Cancer Hospitial not yet accepting patients
    Taiyuan China

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Hutchmed
ID
NCT07718581
Phase
Phase 1/2 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 147 study participants
Last Updated