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NCT04503265 | RECRUITING | Advanced Malignant Neoplasm

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

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

Advanced Malignant Neoplasm

Breast Cancer

Ovarian Cancer

Homologous Recombination Deficiency

Prostate Cancer

Pancreatic Cancer

Intervention/treatment

AMXI-5001:Dose Escalation Phase I

AMXI-5001:Dose Expansion Phase II

Phase

PHASE1

PHASE2

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 122 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 122 participants
Masking : NONE
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 : 2020-08-12
Estimated Primary Completion Date : 2026-08
Estimated Study Completion Date : 2026-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
    • 5. Able to understand and sign consent
    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
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

Location Details

NCT04503265

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

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

Los Angeles, California, United States, 90404

RECRUITING

United States, Maryland

Johns Hopkins

Baltimore, Maryland, United States, 21218

RECRUITING

United States, Tennessee

SCRI Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030