- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2020-08-12
2026-08
2026-10
122
NCT04503265
AtlasMedx, Incorporated
AtlasMedx, Incorporated
INTERVENTIONAL
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
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.
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.
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 | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-07-23 | N/A | 2025-04-29 |
2020-08-04 | N/A | 2025-05-01 |
2020-08-07 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: AMXI-5001 Treatment Single Arm Study, all participants will receive AMXI-5001. | DRUG: AMXI-5001:Dose Escalation Phase I
DRUG: AMXI-5001:Dose Expansion Phase II
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Measure concentration of AMXI-5001 in plasma samples | Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters are calculated. | Approximately 24 months |
| Determine change in anti-tumor activity following administration of AMXI-5001 | Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Progression-free Survival (PFS) are assessed by RECIST V1.1 criteria. | Approximately 24 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Bonnie Wettersten, MS Phone Number: (847) 644-9818 Email: clinicaltrials@atlasmedx.com |
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:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
