Clinical trial NCT04503265: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Malignant Neoplasm
Breast Cancer
Ovarian Cancer
Homologous Recombination Deficiency
Prostate Cancer
Pancreatic Cancer
Keywords: Breast
Ovarian
Prostate
Pancreatic
Refractory
Cancer
Malignancy
BRCA
HRD
AMXI-5001
Progression
PARP Inhibitor
Microtubule inhibitor
Lead sponsor: AtlasMedx, Incorporated
Sponsor class: INDUSTRY
First posted: 2020-08-07
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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 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 Phase to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001.

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
5. Able to understand and sign consent

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

Primary outcomes:
measure: Determine the Maximum Tolerated Dose (MTD)
timeFrame: Approximately 12 months
measure: Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy
timeFrame: Approximately 12 months
measure: Characterize safety profile of AMXI-5001
timeFrame: Approximately 24 months
Secondary outcomes:
measure: Measure concentration of AMXI-5001 in plasma samples
timeFrame: Approximately 24 months
measure: Determine change in anti-tumor activity following administration of AMXI-5001
timeFrame: Approximately 24 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology
state: California
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: AtlasMedx, Incorporated
name: Pamela Munster, MD
role: STUDY_DIRECTOR
References:
citation: Lemjabbar-Alaoui H, Peto CJ, Yang YW, Jablons DM. AMXI-5001, a novel dual parp1/2 and microtubule polymerization inhibitor for the treatment of human cancers. Am J Cancer Res. 2020 Aug 1;10(8):2649-2676. eCollection 2020.