A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
AtlasMedx, Incorporated
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.
Description
AMXI-5001 is an orally available dual PARP (poly adenosine diphosphate \[ADP\] ribose polymerase) and microtubule polymerization inhibitor. ATLAS-101 is a Phase I/II, open label, multi-center, non-randomized Dose Escalation and Dose Expansion study in participants with advanced malignancies. Study enrollment is approximately 122 participants. All participants receive oral AMXI-5001, twice daily, as monotherapy. Following Phase I (Dose Escalation) to identify the Maximum Tolerated Dose and the Recommended Dose for use in Phase II, additional participants will be enrolled into the Dose Expansion…
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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…
Interventions
- DrugAMXI-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.
- DrugAMXI-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.
Locations (4)
- University of California, Los Angles (UCLA) Department of Medicine - Hematology/OncologyLos Angeles, California
- Johns HopkinsBaltimore, Maryland
- SCRI Oncology PartnersNashville, Tennessee
- The University of Texas MD Anderson Cancer CenterHouston, Texas