Study on HMPL-A251 for Advanced or Metastatic HER2-Positive Solid Tumors
Sponsor: Hutchmed
ClinicalTrials ID:NCT07228247
This clinical trial is testing a new drug, HMPL-A251, to see if it is safe and effective for adults with advanced or metastatic solid tumors that express the HER2 protein. The study aims to find the best dose for future research.
Patient Parameters
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Program Overview
This study is the first time HMPL-A251 is being tested in humans. It involves adults with advanced or metastatic solid tumors that cannot be surgically removed and express the HER2 protein. The main goals are to determine the safety of the drug, find the highest dose that can be tolerated, and assess its initial effectiveness in treating these types of cancer.
Description
The trial is divided into two phases: Phase I focuses on determining the safety and the highest dose of HMPL-A251 that patients can tolerate. Phase IIa will explore the effectiveness of the drug at the recommended dose in treating HER2-positive solid tumors. Participants will receive the drug and be monitored for any side effects and how well the cancer responds to the treatment. The study will help decide the best dose for future trials and gather early information on how well the drug works against these cancers.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic cancer that cannot be surgically removed.
- Have at least one tumor that can be measured by scans.
- 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.
- Weigh at least 35 kg (about 77 pounds).
Exclusion Criteria
- Have type I diabetes or uncontrolled type II diabetes.
- Are taking certain medications that affect how the body processes drugs, specifically those that inhibit CYP3A4, P-gp, or BCRP enzymes, within a specified time before starting the study drug.
- Have not recovered from side effects of previous cancer treatments to a mild level, except for hair loss. Some ongoing moderate side effects may be allowed after discussion with the study team.
- Have high levels of certain enzymes (amylase or lipase) in the blood that are considered significant by the study doctors.
- Have untreated or active cancer spread to the brain or spinal cord, or need medication to control symptoms from these conditions.
- Have had major surgery within 28 days before starting the study drug and have not fully recovered from it.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| SCRI HealthONE | 80218 | Denver | Colorado |
| BRCR Global | 33322 | Plantation | Florida |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Cleveland Clinic Taussig Cancer Center | 44195 | Cleveland | Ohio |
| Vanderbilt University Medical Center | 37232 | Nashville | Tennessee |
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