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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official 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
Study sites (4)
CA
- University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology · Los Angeles, CA 90404More trials in Los Angeles
MD
- Johns Hopkins · Baltimore, MD 21218More trials in Baltimore
TN
- SCRI Oncology Partners · Nashville, TN 37203More trials in Nashville
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston