Treatment of advanced cancers with AMXI-5001

A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies

This study is testing a new oral medication called AMXI-5001 to see if it can help adults with advanced cancers that haven't responded to other treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AtlasMedx, Incorporated (industry)
• Locations: 4 sites (Los Angeles, California and 3 other locations)
• Trial ID: NCT04503265 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced malignancies that are refractory to or intolerant of standard therapies.

Not a fit: Patients currently receiving cancer treatment or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced cancers that are resistant to existing therapies.

How similar studies have performed: Other studies involving PARP inhibitors have shown promising results, indicating potential for success with this novel approach.

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

Where this trial is running

Los Angeles, California and 3 other locations

• 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

Conditions: Advanced Malignant Neoplasm, Breast Cancer, Ovarian Cancer, Homologous Recombination Deficiency, Prostate Cancer, Pancreatic Cancer, Breast, Ovarian