Study on HMPL-A830 for Advanced Solid Tumors
Sponsor: Hutchmed
ClinicalTrials ID:NCT07718581
This clinical trial is testing a new drug, HMPL-A830, in adults with advanced solid tumors that cannot be surgically removed and have not responded to standard treatments. The study aims to find the best dose and evaluate the drug's safety and effectiveness.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is the first to test HMPL-A830 in humans and involves participants with advanced solid tumors that cannot be removed by surgery and have not improved with standard treatments. The trial is divided into two parts: Part A will focus on finding the safest dose, while Part B will assess the drug's safety and initial effectiveness at the recommended dose.
Description
The clinical trial is divided into two parts:
Part A: This phase will involve about 57 participants and aims to determine the safest dose of HMPL-A830 that can be given to patients with solid tumors who have already received other treatments. Researchers will monitor participants closely to evaluate the drug's safety and tolerability.
Part B: This phase will include approximately 90 participants and will focus on assessing the safety and initial effectiveness of HMPL-A830 at the recommended dose. The goal is to determine the best dose for future studies in patients with specific types of solid tumors.
Eligibility Criteria
Inclusion Criteria
- Understand the study and voluntarily agree to participate by signing a consent form.
- Be 18 years or older.
- Have a confirmed diagnosis of an advanced solid tumor that cannot be surgically removed.
- Have at least one tumor that can be measured using standard criteria.
- Have a life expectancy of at least 12 weeks.
- Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
Exclusion Criteria
- Use of certain medications that affect the liver enzyme CYP3A4 or proteins P-gp and BCRP within a specified time before starting the study drug.
- Have had major surgery within 28 days before starting the study drug.
- Have an active infection that requires treatment.
- Have a history of inflammatory bowel diseases.
- Have an allergy to any component of HMPL-A830.
- Be pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California Irvine Medical Center | 92868 | Orange | California |
| BRCR Global | 33065 | Coral Springs | Florida |
| Florida Clinical Trials Group | 33322 | Plantation | Florida |
| START New Jersey | 08816 | East Brunswick | New Jersey |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| START Mountain Region | 84119 | West Valley City | Utah |
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