A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
Recruiting · NCT04503265 · Interventional (participants receive a specific treatment) · Lead sponsor: AtlasMedx, Incorporated
View the official record on ClinicalTrials.gov →Interventions studied
AMXI-5001:Dose Escalation Phase IAMXI-5001:Dose Expansion Phase II
What this trial is about
ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Key Factors):
- 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
- Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Eastern Co-operative Oncology Group (ECOG) PS 0-1
- Participant must be 18 years of age or older
- 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
Where it is running
4 locations listed across 4 US states.
- University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology - Los Angeles, California, United States
- Johns Hopkins - Baltimore, Maryland, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- The University of Texas MD Anderson Cancer Center - Houston, Texas, United States