RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2020-08-12
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04503265

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Bonnie Wettersten, MS
CONTACT
(847) 644-9818
clinicaltrials@atlasmedx.com

Principal Investigator

Pamela Munster, MD
STUDY_DIRECTOR
AtlasMedx, Incorporated

Study Locations (Sites)

University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles, California, 90404
United States
Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
United States
Johns Hopkins
Baltimore, Maryland, 21218
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: AtlasMedx, Incorporated

  • Pamela Munster, MD, STUDY_DIRECTOR, AtlasMedx, Incorporated

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-12
Study Completion Date2026-10

Study Record Updates

Study Start Date2020-08-12
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Breast
  • Ovarian
  • Prostate
  • Pancreatic
  • Refractory
  • Cancer
  • Malignancy
  • BRCA
  • HRD
  • AMXI-5001
  • Progression
  • PARP Inhibitor
  • Microtubule inhibitor

Additional Relevant MeSH Terms

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