A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
1 other identifier
interventional
122
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2020
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
August 7, 2020
CompletedStudy Start
First participant enrolled
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
May 1, 2025
April 1, 2025
6 years
July 23, 2020
April 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Determine the Maximum Tolerated Dose (MTD)
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.
Approximately 12 months
Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy
The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Approximately 12 months
Characterize safety profile of AMXI-5001
The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.
Approximately 24 months
Secondary Outcomes (2)
Measure concentration of AMXI-5001 in plasma samples
Approximately 24 months
Determine change in anti-tumor activity following administration of AMXI-5001
Approximately 24 months
Study Arms (1)
AMXI-5001 Treatment
EXPERIMENTALSingle Arm Study, all participants will receive AMXI-5001.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
- Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
- Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
- Malignancy has progressed after standard therapy
- Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
- Eastern Co-operative Oncology Group (ECOG) PS 0-1
- Participant must be 18 years of age or older
- Able to understand and sign consent
You may not qualify if:
- Receiving cancer treatment at the time of enrollment
- Any clinically significant disease or condition affecting a major organ system
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- 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)
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles, California, 90404, 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
Related Publications (1)
Lemjabbar-Alaoui H, Peto CJ, Yang YW, Jablons DM. AMXI-5001, a novel dual parp1/2 and microtubule polymerization inhibitor for the treatment of human cancers. Am J Cancer Res. 2020 Aug 1;10(8):2649-2676. eCollection 2020.
PMID: 32905466BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pamela Munster, MD
AtlasMedx, Incorporated
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2020
First Posted
August 7, 2020
Study Start
August 12, 2020
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
May 1, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share