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NCT04503265 · ClinicalTrials.gov registry record · Phase 1
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by AtlasMedx, Incorporated.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
- 4
- Study locations
NCT04503265: Recruiting Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by AtlasMedx, Incorporated.
NCT04503265 is a Phase 1 study of Breast Cancer and Prostate Cancer that is actively recruiting participants, run by AtlasMedx, Incorporated. The registered enrollment target is 122 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04503265, a Phase 1 study of Breast Cancer and Prostate Cancer, is actively recruiting participants, sponsored by AtlasMedx, Incorporated.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
- 4
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG AMXI-5001:Dose Escalation Phase I
- DRUG AMXI-5001:Dose Expansion Phase II
Study Locations (4)
California
- University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology - Los Angeles
Maryland
- Johns Hopkins - Baltimore
Tennessee
- SCRI Oncology Partners - Nashville
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2020-08-12 |
| Est. Completion | 2026-10 |
| Phase | Phase 1 |
What NCT04503265 shows while recruiting
NCT04503265 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which AMXI-5001:Dose Escalation Phase I is the first listed.
NCT04503265 reports a single indexed study location in California, Maryland, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04503265 about?
NCT04503265 is a clinical study titled "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 chara...
What is the current status of trial NCT04503265?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2020-08-12. Estimated completion is 2026-10.
What conditions does trial NCT04503265 study?
This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Ovarian Cancer, Pancreatic Cancer, Advanced Malignant Neoplasm.
What interventions are being tested in trial NCT04503265?
The interventions under investigation include: AMXI-5001:Dose Escalation Phase I (DRUG), AMXI-5001:Dose Expansion Phase II (DRUG).
Who is sponsoring clinical trial NCT04503265?
This trial is sponsored by AtlasMedx, Incorporated, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04503265 being conducted?
This trial has 4 study locations across California, Maryland, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04503265's enrollment target sits among peer trials
122 505th of 1224 higher than 720 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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