Status:
RECRUITING
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
Lead Sponsor:
AtlasMedx, Incorporated
Conditions:
Advanced Malignant Neoplasm
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 (Dos...
Detailed Description
AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate \[ADP\] ribose polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label, multi-center, non-ran...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04503265
Start Date
August 12 2020
End Date
October 1 2026
Last Update
May 1 2025
Active Locations (4)
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1
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90404
2
Johns Hopkins
Baltimore, Maryland, United States, 21218
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030