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A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
Trial Status: active
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.
Inclusion 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
Additional locations may be listed on ClinicalTrials.gov for NCT04503265.
