RecruitingPhase 1Phase 2NCT04503265

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

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

Sponsor

AtlasMedx, Incorporated

Enrollment

122 participants

Start Date

Aug 12, 2020

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Pancreatic Cancer Ovarian Cancer Prostate Cancer Homologous Recombination Deficiency Advanced Malignant Neoplasm

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new experimental drug called AMXI-5001 in people with advanced or metastatic solid tumors whose cancer is no longer responding to standard treatments. **You may be eligible if...** - You have an advanced or metastatic solid tumor (cancer that has spread) - Standard treatments are no longer working, you cannot tolerate them, or no standard therapy exists for your cancer type - You are 18 or older and in reasonable overall health - You have measurable cancer on imaging scans **You may NOT be eligible if...** - You are currently receiving other cancer treatments - You have active brain metastases (cancer spread to the brain) - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAMXI-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.

DRUGAMXI-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

View Full Details on ClinicalTrials.gov

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NCT04503265

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