Open Actively Recruiting

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

About

Brief Summary

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion 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

Exclusion Criteria (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

Join this Trial

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Study Stats
Protocol No.
19-002234
Category
Hematology-Oncology
Oncology
Contact
CHRISTOPHER LIM
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04503265
For detailed technical eligibility, visit ClinicalTrials.gov.