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
The main objective of the intervention(s) being evaluated by the clinical trial. Learn more
Treatment
Study Type
The nature of the investigation or investigational use for which clinical study information is being submitted. Learn more
Interventional
Phase
Phase 1/Phase 2

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
  • Able to understand and sign consent

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

Contact our clinical trial navigators for opportunities that may be suitable for you
Pre-Screen Now
Call Me Back
855-731-6040
Study Stats
Protocol No.
19-002234
Category
Adolescent & Young Adults (AYA)
Bladder Cancer
Breast Cancer
Cervical Cancer
Colorectal Cancer
Esophageal Cancer
Gallbladder Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin Cancer)
Non-Melanoma Skin Cancer
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Sarcoma
Stomach Cancer
Uterine/Endometrial Cancer
Principal Investigator
Contact
  • Christopher Lim
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT04503265
For detailed technical eligibility, visit ClinicalTrials.gov.