A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed 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 82 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 Phase to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AMXI-5001 Treatment Single Arm Study, all participants will receive AMXI-5001. |
Drug: AMXI-5001:Dose Escalation Phase I
Phase I will enroll up to 30 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, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.
Other Names:
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, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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.
Secondary Outcome Measures
- 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.
- Measure concentration of AMXI-5001 in plasma samples [Approximately 24 months]
Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters are calculated.
- 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.
- Determine change in anti-tumor activity following administration of AMXI-5001 [Approximately 24 months]
Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Progression-free Survival (PFS) are assessed by RECIST V1.1 criteria.
Eligibility Criteria
Criteria
Inclusion Criteria (Key Factors):
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Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
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Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
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Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
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Malignancy has progressed after standard therapy
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Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.
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Eastern Co-operative Oncology Group (ECOG) PS 0-1
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Participant must be 18 years of age or older
Exclusion Criteria (Key Factors):
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Receiving cancer treatment at the time of enrollment
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Any clinically significant disease or condition affecting a major organ system
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Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
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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)
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Has had a previous (within 2 years) or has a current malignancy other than the target cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Honor Health | Phoenix | Arizona | United States | 85374 |
| 2 | University of California, Davis (UC Davis) | Davis | California | United States | 95616 |
| 3 | University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology | Los Angeles | California | United States | 90404 |
| 4 | Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 5 | Johns Hopkins | Baltimore | Maryland | United States | 21218 |
| 6 | The Sarah Cannon Research Institute/Tennessee Oncology | Nashville | Tennessee | United States | 37203 |
| 7 | Vanderbilt University | Nashville | Tennessee | United States | 37235 |
| 8 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- AtlasMedx, Incorporated
Investigators
- Study Director: Robert Reder, MD, AtlasMedx, Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- ATLAS-101