NCT04503265RecruitingPhase 1/2
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
Source: ClinicalTrials.gov · Last updated 1 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 122 (estimated)
- First submitted
- 23 Jul 2020
- Start date
- 12 Aug 2020
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- AtlasMedx, Incorporated
- Diseases
- Prostate cancer, Pancreatic cancer, Ovarian cancer
- NCT number
- NCT04503265
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 122
- From 12 Aug 2020 to the primary completion date, 31 Aug 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving cancer treatment at the time of enrollment
- 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
Other illness
- Any clinically significant disease or condition affecting a major organ system
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| The University of Texas MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.