A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

Launched by ATLASMEDX, INCORPORATED · Aug 4, 2020

Keywords

ClinConnect Summary

The clinical trial titled "A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies" is investigating a new treatment called AMXI-5001 for adults with advanced cancers, including breast, ovarian, prostate, and pancreatic cancers. This study is designed for patients who have not responded well to previous therapies or cannot tolerate them. The trial has two parts: the first part will find the best dose of the treatment, and the second part will look at how safe and effective it is for patients.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of advanced cancer that is either resistant to current treatments or has worsened after standard therapies. Participants should not be receiving any other cancer treatments at the time they join the study. During the trial, patients will receive AMXI-5001 and undergo regular check-ups to monitor their health and the effects of the treatment. If you or someone you know is considering joining, it's important to talk with a healthcare provider to understand the potential benefits and risks.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (Key Factors):
• 1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
• • 1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
• • 2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
• • 3. Malignancy has progressed after standard therapy
• • 2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
• • 3. Eastern Co-operative Oncology Group (ECOG) PS 0-1
• • 4. Participant must be 18 years of age or older
• • 5. Able to understand and sign consent
• Exclusion Criteria (Key Factors):
• • 1. Receiving cancer treatment at the time of enrollment
• • 2. Any clinically significant disease or condition affecting a major organ system
• • 3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
• • 4. 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)
• • 5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer