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 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

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