NCT04503265 A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
| NCT ID | NCT04503265 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | AtlasMedx, Incorporated |
| Condition | Advanced Malignant Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 122 participants |
| Start Date | 2020-08-12 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 122 participants in total. It began in 2020-08-12 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria (Key Factors): 1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following: 1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition 2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit 3. Malignancy has progressed after standard therapy 2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy. 3. Eastern Co-operative Oncology Group (ECOG) PS 0-1 4. Participant must be 18 years of age or older 5. Able to understand and sign consent Exclusion Criteria (Key Factors): 1. Receiving cancer treatment at the time of enrollment 2. Any clinically significant disease or condition affecting a major organ system 3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities 4. 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) 5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer
Contact & Investigator
Pamela Munster, MD
STUDY DIRECTOR
AtlasMedx, Incorporated
Frequently Asked Questions
Who can join the NCT04503265 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignant Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04503265 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04503265 currently recruiting?
Yes, NCT04503265 is actively recruiting participants. Contact the research team at clinicaltrials@atlasmedx.com for enrollment information.
Where is the NCT04503265 trial being conducted?
This trial is being conducted at Los Angeles, United States, Baltimore, United States, Nashville, United States, Houston, United States.
Who is sponsoring the NCT04503265 clinical trial?
NCT04503265 is sponsored by AtlasMedx, Incorporated. The principal investigator is Pamela Munster, MD at AtlasMedx, Incorporated. The trial plans to enroll 122 participants.