Treatment of advanced cancers with AMXI-5001

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates AMXI-5001, an oral medication that inhibits PARP and microtubule polymerization, in adults with advanced malignancies who have not responded to previous therapies. The trial consists of two phases: Phase I focuses on determining the maximum tolerated dose, while Phase II aims to assess the safety and efficacy of the drug. Approximately 122 participants will receive AMXI-5001 twice daily as a monotherapy. The study is designed to provide insights into the pharmacological effects and clinical outcomes associated with this treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
  Los Angeles, California, United States Recruiting
• Johns Hopkins
  Baltimore, Maryland, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Bonnie Wettersten, MS
• Email: clinicaltrials@atlasmedx.com
• Phone: (847) 644-9818

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.