Description:
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.
Title
- Brief Title: A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
- Official Title: A Phase I/II, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies
Clinical Trial IDs
- ORG STUDY ID:
ATLAS-101
- NCT ID:
NCT04503265
Conditions
- Advanced Malignant Neoplasm
- Breast Cancer
- Ovarian Cancer
- Homologous Recombination Deficiency
Interventions
Drug | Synonyms | Arms |
---|
AMXI-5001:Dose Escalation Phase I | Phase I, Dose Escalation | AMXI-5001 Treatment |
AMXI-5001: Dose Expansion Phase II | Phase II, Dose Expansion | AMXI-5001 Treatment |
Purpose
ATLAS-101 is a Phase I/II clinical trial of AMXI-5001 in 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. The
purpose of Phase II (dose expansion) is to characterize the safety and efficacy of AMXI-5001.
Detailed Description
AMXI-5001 is a 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 80 participants. Participants receive oral AMXI-5001, twice
daily, as monotherapy. The Dose Escalation Phase is a standard 3+3 escalation scheme.
Following the identification of the Maximum Tolerated Dose in Phase I 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.
Trial Arms
Name | Type | Description | Interventions |
---|
AMXI-5001 Treatment | Experimental | Single Arm Study, all participants will receive AMXI-5001. | - AMXI-5001:Dose Escalation Phase I
- AMXI-5001: Dose Expansion Phase II
|
Eligibility Criteria
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
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Determine dose-limiting toxicity (DLT) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | Determine the DLT of AMXI-5001 (in milligrams) |
Secondary Outcome Measures
Measure: | Determine Duration of Response (DOR) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Determine DOR as the time from documentation of tumor response to disease progression. |
Measure: | Determine Progression-free Survival (PFS) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Determine PFS as the time from study enrollment until objective tumor progression or death. |
Measure: | Determine Overall Survival (OS) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Determine OS as the time from study entry to death from any cause. |
Measure: | Measure concentration of AMXI-5001 in plasma samples |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Concentrations of AMXI-5001 in plasma samples at different time points are measured. Standard pharmacokinetic parameters will be calculated. |
Measure: | Characterize safety profile of AMXI-5001 |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Characterize the safety profile of AMXI-5001 by incidence of treatment emergent adverse events, standard hematologic, chemistry, and ECG measurements. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AtlasMedx, Incorporated |
Trial Keywords
- Breast
- Ovarian
- Refractory
- Cancer
- Malignancy
- BRCA
- HRD
- AMXI-5001
- Progression
- PARP Inhibitor
- Microtubule inhibitor
Last Updated
August 4, 2020