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
- Prostate Cancer
- Pancreatic Cancer
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 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.
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.
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
4. Participant must be 18 years of age or older
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 the Maximum Tolerated Dose (MTD) |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | 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
Measure: | Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy |
Time Frame: | Approximately 12 months |
Safety Issue: | |
Description: | The RP2D is based upon the review of all available data including safety, pharmacokinetic, preliminary anti-tumor activity, and MTD. |
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 are calculated. |
Measure: | Characterize safety profile of AMXI-5001 |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | The safety profile of AMXI-5001 is defined by the incidence of treatment emergent adverse events, laboratory abnormalities, and ECG measurements. |
Measure: | Determine change in anti-tumor activity following administration of AMXI-5001 |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Overall Survival (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Progression-free Survival (PFS) are assessed by RECIST V1.1 criteria. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | AtlasMedx, Incorporated |
Trial Keywords
- Breast
- Ovarian
- Prostate
- Pancreatic
- Refractory
- Cancer
- Malignancy
- BRCA
- HRD
- AMXI-5001
- Progression
- PARP Inhibitor
- Microtubule inhibitor
Last Updated
February 25, 2021