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

Part of paid clinical trials in Los Angeles, California.

Sponsor
AtlasMedx, Incorporated
Study ID
NCT04503265
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AMXI-5001:Dose Escalation Phase I — DRUG
    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.
  • AMXI-5001:Dose Expansion Phase II — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 12, 2020
Status verified
Apr 2025
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
122 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AMXI-5001 Treatment
    Single Arm Study, all participants will receive AMXI-5001.

Primary Outcome Measure

Determine the Maximum Tolerated Dose (MTD) [ Time Frame: Approximately 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, Los Angles (UCLA) Department of Medicine - Hematology/OncologyLos AngelesCalifornia90404-
Johns HopkinsBaltimoreMaryland21218-
SCRI Oncology PartnersNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology· Los Angeles, CAJohns Hopkins· Baltimore, MDSCRI Oncology Partners· Nashville, TNThe University of Texas MD Anderson Cancer Center· Houston, TX

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