AMXI-5001, a novel dual parp1/2 and microtubule polymerization inhibitor for the treatment of human cancers.
Hassan Lemjabbar-Alaoui, Csaba J Peto, Yi-Wei Yang...
https://pubmed.ncbi.nlm.nih.gov/32905466Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID04503265
A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
Led by AtlasMedx, Incorporated · Updated on 2025-05-01
122
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AMXI-5001, an oral drug that blocks PARP and microtubule polymerization, in adults with advanced cancers that have not responded to other treatments. This Phase I/II trial aims first to find the best dose and then to study the drug's safety and effects in more detail. The study includes participants with several types of advanced cancers, including breast, ovarian, prostate, pancreatic, and other malignant tumors. The trial has two parts: Phase I involves dose escalation, where up to 70 participants receive AMXI-5001 orally twice a day with food on a weekly continuous 7-day schedule, with each treatment cycle lasting 28 days. After determining the recommended dose, Phase II will enroll up to 52 participants to further assess safety, drug levels in the blood, and anti-tumor activity using the chosen dose. All participants receive the study drug as monotherapy. Participants will be monitored for safety, drug concentration in plasma, and tumor response using standard imaging and laboratory tests over approximately 24 months. The primary goals include finding the maximum tolerated dose and recommended dose for Phase II, as well as characterizing the safety profile. Participants must consent and meet eligibility criteria related to their cancer status and overall health. The trial will continue until about October 2026.
CONDITIONS
Brief Title
A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have a confirmed advanced or metastatic cancer that is intolerant, refractory, or has progressed after standard therapy
- Have measurable or evaluable tumors by standard assessments
- Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1
- Able to understand and sign informed consent
You will not qualify if you...
- Receiving cancer treatment at the time of enrollment
- Have any significant disease or condition affecting a major organ system
- Have significant cardiovascular disease or abnormal electrocardiogram (ECG)
- Use of strong CYP3A4 inhibitors or inducers within 7 days before starting the study and throughout
- Have had another malignancy within the past 2 years or currently have a different cancer than the target malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 24 months
Participants receive oral AMXI-5001 twice daily as monotherapy in 28-day continuous cycles to treat advanced malignancies.
Weekly visits for treatment and assessments
Trial Site Locations
Total: 4 locations
1
University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90404
Actively Recruiting
2
Johns Hopkins
Baltimore, Maryland, United States, 21218
Actively Recruiting
3
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
B
Bonnie Wettersten, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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