AMXT 1501 Updates
As of November 2022, Aminex Therapeutics completed enrollment of patients into the Expansion part of their Phase 1 AMXT1501-101A clinical study, consisting of AMXT 1501 in combination with DFMO in oral capsule formulation. Aminex Therapeutics has opened a new formulation study as of August 2022, available for patients with DIPG, DMG and other solid tumors ages 12 years and older and that weigh more than 40 kg (88 lbs).
This Phase 1B/2A trial will evaluate AMXT 1501 (oral capsule) in combination with DFMO in an intravenous formulation in adult patients with advanced solid tumor cancers, and both adolescent and adult patients with DIPG/DMG (ages 12 and above). The Phase 1B primary objectives are to establish both safety and the recommended Phase 2 dose for Aminex’s dual drug treatment. The Phase 2A goal is to evaluate the dual drug treatment in an array of cancers to assist in determining the cancer selection(s) for future Phase 2 studies. This trial utilizes a small ambulatory pump to continuously administer DFMO to patients. The pump and IV bag are contained in a small lightweight pouch that is carried by patients as they go about their daily activities. IV bags are changed weekly.
Future cohorts will increase the dose of IV DFMO while holding the oral AMXT-1501 dose steady.
Additional details are available at clinicaltrials.gov (see https://clinicaltrials.gov/ and search for “Aminex” in the “Other Terms” search field). You can also be notified of new and updated DIPG/DMG trials by signing up at trials.dipg.org.
Trial locations include:
Cincinnati Children's Hospital Medical Center (Recruiting)
Adolescent patients - 12 years old and older; DIPG/DMG patients only
Cincinnati, Ohio, United States, 45229
Contact: Clinical trials office 513-636-2799 [email protected]
Principal Investigator: Trent Hummel, MD
MD Anderson Cancer Center (Recruiting)
Patients - 12 yo and older, DIPG/DMG and 18 yo older other cancers
Houston, Texas, United States, 77030
Contact: Rabia Khan 713-563-4667 [email protected]
Principal Investigator: Sarina Piha-Paul, MD
Sub-Investigator: Wafik Zaky, MD
Fred Hutch Cancer Center - Seattle Cancer Care Alliance (Recruiting)
Adult patients – 18 yo and older
Seattle, Washington, United States, 98109
Contact: LyTieng Huot [email protected]
Principal Investigator: John Liao, MD
Mayo Clinic (Planned recruitment to begin in June 2023)
Adult patients - 18 yo and older
Rochester, MN
Principal Investigator: Dr. Sani Kizilbash
Scottsdale, AZ
Principal Investigator: Dr. Mahesh Seetheram
Jacksonville, FL
Principal Investigator: Dr. Jason Starr
Aminex is also collaborating and discussing details with several non-profit organizations, including The Cure Starts Now, who have expressed interest in supporting pediatric trials, under Aminex’s current Investigational New Drug (IND) application with the FDA. These trials will include patients diagnosed with DMG/DIPG and neuroblastoma. We envision these trials starting later in 2023.
In need of financial assistance?
Patients/families enrolled in the Oral AMXT 1501 trial may be eligible to receive financial assistance if they are unable to financially support the patient participating in the trial.
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