No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
122 (estimated)
Sponsor
AtlasMedx, Incorporated · Industry
Who this trial is looking for
This trial is looking for adults with advanced cancers who have not responded to other treatments. Participants will receive the drug AMXI-5001 to see how it works and its safety.
Are You a Good Fit for This Trial?
You may be able to join if
I have advanced cancer that has not responded to treatment.
I have measurable tumors.
I am 18 years or older.
I can understand and sign consent.
You may not be able to join if
I am currently receiving cancer treatment.
I have a significant disease affecting my major organs.
I have serious heart disease or heart rhythm problems.
I have taken certain medications that affect the liver within the last week.
I have had another type of cancer within the last two years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 Locations
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Facility
City
State
Country
Status
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 t…
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
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