Advanced Malignant NeoplasmBreast CancerOvarian CancerHomologous Recombination DeficiencyProstate CancerPancreatic Cancer
Investigational drug(s) / intervention(s)
AMXI-5001:Dose Escalation Phase IAMXI-5001:Dose Expansion Phase II
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.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Determine the Maximum Tolerated Dose (MTD) — Approximately 12 months The highest dose is defined at which no more than 1 of 6 evaluable participants has had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria and determination by Investigator and Data and Safety Monitoring Committee.
Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy — Approximately 12 months The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD.
Characterize safety profile of AMXI-5001 — Approximately 24 months The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements.
Trial sites (4)
Facility
City
Region
Status
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles
California
Recruiting
Johns Hopkins
Baltimore
Maryland
Recruiting
SCRI Oncology Partners
Nashville
Tennessee
Recruiting
The University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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