A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT04503265|
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : February 25, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Neoplasm Breast Cancer Ovarian Cancer Homologous Recombination Deficiency Prostate Cancer Pancreatic Cancer||Drug: AMXI-5001:Dose Escalation Phase I Drug: AMXI-5001:Dose Expansion Phase II||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 12, 2020|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
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.
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.
- Determine the Maximum Tolerated Dose (MTD) [ Time Frame: 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.
- Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503265
|Contact: Bonnie Wettersten, MS||(847) firstname.lastname@example.org|
|United States, Arizona|
|Honor Health||Not yet recruiting|
|Phoenix, Arizona, United States, 85374|
|United States, California|
|University of California, Davis (UC Davis)||Not yet recruiting|
|Davis, California, United States, 95616|
|University of California, Los Angles (UCLA) Department of Medicine - Hematology/Oncology||Recruiting|
|Los Angeles, California, United States, 90404|
|United States, Florida|
|Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Maryland|
|Johns Hopkins||Not yet recruiting|
|Baltimore, Maryland, United States, 21218|
|United States, Tennessee|
|The Sarah Cannon Research Institute/Tennessee Oncology||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Vanderbilt University||Not yet recruiting|
|Nashville, Tennessee, United States, 37235|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Director:||Robert Reder, MD||AtlasMedx, Inc|