A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
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.
• 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