Recruiting

A Trial of AMXI-5001 for Treatment 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.

ClinicalTrials.gov IDNCT04503265

PhasePHASE1, PHASE2

Enrollment122

SponsorAtlasMedx, Incorporated

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Advanced Malignant Neoplasm, Breast Cancer, Ovarian Cancer, Homologous Recombination Deficiency, Prostate Cancer, Pancreatic Cancer

About this study

Interventions

Drug: AMXI-5001:Dose Escalation Phase I — Phase I will enroll up to 70 participants to identify the Recommended Phase II daily dose in the treatment of various cancers and to characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.
Drug: AMXI-5001:Dose Expansion Phase II — Phase II will enroll up to 52 study participants to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, with food. AMXI-5001 is administered weekly on a continuous 7-day schedule. Each cycle is 28 days.

Primary outcomes

Determine the Maximum Tolerated Dose (MTD) (Approximately 12 months)
Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy (Approximately 12 months)
Characterize safety profile of AMXI-5001 (Approximately 24 months)

Eligibility information

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

Study locations

University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology, Los Angeles, California 90404 United States
Johns Hopkins, Baltimore, Maryland 21218 United States
SCRI Oncology Partners, Nashville, Tennessee 37203 United States
The University of Texas MD Anderson Cancer Center, Houston, Texas 77030 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.