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RECRUITING
NCT04503265
PHASE1/PHASE2

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

Sponsor: AtlasMedx, Incorporated

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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