Study on AMXI-5001 for Treating Advanced Cancers
Sponsor: AtlasMedx, Incorporated
ClinicalTrials ID:NCT04503265
This clinical trial is testing a new drug, AMXI-5001, in adults with advanced cancers that have not responded to other treatments. The study aims to find the best dose and evaluate the safety and effectiveness of the drug.
Patient Parameters
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Program Overview
The ATLAS-101 study is exploring a new treatment called AMXI-5001 for adults with advanced cancers that have not improved with other therapies. The study has two parts: Phase I focuses on finding the right dose, and Phase II looks at how safe and effective the drug is.
Description
AMXI-5001 is a new oral medication that targets cancer cells by blocking certain proteins and processes they need to grow. The ATLAS-101 study is being conducted in multiple locations and involves two main phases. In Phase I, researchers will determine the safest and most effective dose of AMXI-5001 by gradually increasing the dose given to participants. Once the best dose is identified, Phase II will begin, where more participants will receive the drug to further assess its safety and how well it works against cancer. A total of about 122 participants will take part in the study, and all will receive AMXI-5001 as a pill taken twice a day. The study aims to provide valuable information on the drug's safety, how it behaves in the body, and its potential benefits for treating advanced cancers.
Eligibility Criteria
Inclusion Criteria (Key Factors):
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Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
- Malignancy has progressed after standard therapy
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Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
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Eastern Co-operative Oncology Group (ECOG) PS 0-1
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Participant must be 18 years of age or older
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Able to understand and sign consent
Exclusion Criteria (Key Factors):
- Receiving cancer treatment at the time of enrollment
- Any clinically significant disease or condition affecting a major organ system
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology | 90404 | Los Angeles | California |
| Moffitt Cancer Center and Research Institute | 33612 | Tampa | Florida |
| Johns Hopkins | 21218 | Baltimore | Maryland |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
| The University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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