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A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
Sponsor: AtlasMedx, Incorporated
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 (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.
Official title: A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2020-08-12
Completion Date
2026-10
Last Updated
2025-05-01
Healthy Volunteers
No
Conditions
Interventions
AMXI-5001:Dose Escalation Phase I
Phase I will enroll up to 70 participants to identify the Recommended Phase II daily dose in the treatment of various cancers and to characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.
AMXI-5001:Dose Expansion Phase II
Phase II will enroll up to 52 study participants to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.
Locations (4)
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