Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT04503265

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

Led by AtlasMedx, Incorporated · Updated on 2025-05-01

122

Participants Needed

4

Research Sites

320 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Pathologically confirmed advanced or metastatic malignancy that is intolerant, refractory, or progressed after standard therapy
  • Measurable tumors by standard imaging or laboratory tests
  • Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
  • Able to understand and sign informed consent
Not Eligible

You will not qualify if you...

  • Receiving cancer treatment at enrollment
  • Any clinically significant disease affecting a major organ system
  • Significant cardiovascular disease or abnormal electrocardiogram (ECG) findings
  • Use of strong CYP3A4 inhibitors or inducers within 7 days before starting study therapy and during the study
  • History of another malignancy within the past 2 years or current malignancy other than the target cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology

Los Angeles, California, United States, 90404

Actively Recruiting

2

Johns Hopkins

Baltimore, Maryland, United States, 21218

Actively Recruiting

3

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

Actively Recruiting

4

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

B

Bonnie Wettersten, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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