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New treatment option for Advanced Malignant Neoplasm
Official title A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
ClinicalTrials.gov ID: NCT04503265
What this study is testing
What is AMXI-5001:Dose Escalation Phase I?
AMXI-5001:Dose Escalation Phase I is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for advanced malignant neoplasm.
Also referred to as Phase I, Dose Escalation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (Key Factors):
- 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
You likely can't join if
- (Key Factors):
- Receiving cancer treatment at the time of enrollment
- Any clinically significant disease or condition affecting a major organ system
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- 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...
- Has had a previous (within 2 years) or has a current malignancy other than the target cancer
See the full eligibility criteria
- (Key Factors):
- 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
- (Key Factors):
- Receiving cancer treatment at the time of enrollment
- Any clinically significant disease or condition affecting a major organ system
- Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Baltimore, Maryland, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Baltimore, Maryland, United States; Nashville, Tennessee, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.