Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04503265
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
AtlasMedx, Incorporated

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Breast Cancer Ovarian Cancer Homologous Recombination Deficiency Prostate Cancer Pancreatic Cancer Drug: AMXI-5001:Dose Escalation Phase I Drug: AMXI-5001:Dose Expansion Phase II Phase 1 Phase 2

Detailed Description:
AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate [ADP] ribose polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label, multi-center, non-randomized Dose Escalation and Dose Expansion study in participants with advanced malignancies. Study enrollment is approximately 82 participants. All participants receive oral AMXI-5001, twice daily, as monotherapy. Following Phase I (Dose Escalation) to identify the Maximum Tolerated Dose and the Recommended Dose for use in Phase II, additional participants will be enrolled into the Dose Expansion Phase to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023


Arm Intervention/treatment
Experimental: AMXI-5001 Treatment
Single Arm Study, all participants will receive AMXI-5001.
Drug: AMXI-5001:Dose Escalation Phase I
Phase I will enroll up to 30 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, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.
Other Names:
  • Phase I
  • Dose Escalation

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, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.
Other Names:
  • Phase II
  • Dose Expansion




Primary Outcome Measures :
  1. Determine the Maximum Tolerated Dose (MTD) [ Time Frame: Approximately 12 months ]
    The highest dose is defined at which no more than 1 of 6 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.


Secondary Outcome Measures :
  1. Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy [ Time Frame: Approximately 12 months ]
    The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.

  2. Measure concentration of AMXI-5001 in plasma samples [ Time Frame: Approximately 24 months ]
    Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters are calculated.

  3. Characterize safety profile of AMXI-5001 [ Time Frame: Approximately 24 months ]
    The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.

  4. Determine change in anti-tumor activity following administration of AMXI-5001 [ Time Frame: Approximately 24 months ]
    Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Progression-free Survival (PFS) are assessed by RECIST V1.1 criteria.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Key Factors):

  1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:

    1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
    2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
    3. Malignancy has progressed after standard therapy
  2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
  3. Eastern Co-operative Oncology Group (ECOG) PS 0-1
  4. Participant must be 18 years of age or older

Exclusion Criteria (Key Factors):

  1. Receiving cancer treatment at the time of enrollment
  2. Any clinically significant disease or condition affecting a major organ system
  3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
  4. Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)
  5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503265


Contacts
Layout table for location contacts
Contact: Bonnie Wettersten, MS (847) 644-9818 clinicaltrials@atlasmedx.com

Locations
Layout table for location information
United States, Arizona
Honor Health Not yet recruiting
Phoenix, Arizona, United States, 85374
United States, California
University of California, Davis (UC Davis) Not yet recruiting
Davis, California, United States, 95616
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology Recruiting
Los Angeles, California, United States, 90404
United States, Florida
Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
United States, Maryland
Johns Hopkins Not yet recruiting
Baltimore, Maryland, United States, 21218
United States, Tennessee
The Sarah Cannon Research Institute/Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37235
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
AtlasMedx, Incorporated
Investigators
Layout table for investigator information
Study Director: Robert Reder, MD AtlasMedx, Inc
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: AtlasMedx, Incorporated
ClinicalTrials.gov Identifier: NCT04503265    
Other Study ID Numbers: ATLAS-101
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AtlasMedx, Incorporated:
Breast
Ovarian
Prostate
Pancreatic
Refractory
Cancer
Malignancy
BRCA
HRD
AMXI-5001
Progression
PARP Inhibitor
Microtubule inhibitor
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms