Phase 1 Study of Oral Drug PMD-026 in People With Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer
Phase 1/1b Study of Oral Drug PMD-026 in People with Metastatic Breast Cancer and Metastatic Triple Negative Breast Cancer
About the Study
PMD-026 is a study for people who have been diagnosed with metastatic triple negative breast cancer (mTNBC) who have no further treatment options. This research study is investigating if a study drug called PMD-026 is safe and effective for patients with mTNBC.
Type of Study
This is a Phase 1/1b, study of a new oral drug called PMD-026. This drug is not a chemotherapy. The goal is to assess if PMD-026 is safe and effective.
- The agent, PMD-026 is taken orally.
- There is no placebo, everyone in the study will receive the study agent.
What the Study Entails
- Women and men with a diagnosis of metastatic triple negative breast cancer may be screened for eligibility
- Participants will be asked to take two capsules by mouth, twice a day (total 4 capsules daily)
- Participants will be asked to take two capsules with food once to determine if food helps with absorption of PMD-026
- Participants will have 3 weekly clinic visits for health assessments and blood tests in the first treatment cycle, and minimum one visit per cycle thereafter (Each cycle is 21 days)
- CT/MRI scans to assess disease are scheduled for the first 2 cycles then every 9 weeks thereafter
- Participants will receive a safety follow-up approximately 28 days after their last dose
- Once a patient has completed the treatment, and if they did not develop progressive disease while on PMD-026, the study staff will follow up on the patient’s status on a regular basis for up to one year. The follow up will not require a clinic visit, as the study staff can either check the medical record or call the patient
The study is open in the following states
- Gilbert: Banner Health MD Anderson; Study PI: Dr. Lida Mina
Contact: Toni Korpela 480-256-5464 or by email
- Tucson: University of Arizona; Study PI: Dr. Pavani Chalasani;
Contact: Alexia Demitsas 520-694-9089 or by email
- Los Angeles: University of California, Los Angeles; Study PI: Dr. Sara Hurvitz;
Contact: Monica Rocha 310-998-4747 ext 16907 or by email
- San Diego: University of California, San Diego; Study PI: Dr.Rebecca Shatsky;
Contact: Haifa Mshaiel 858-822-4343 or by email
Sauntee Braddock 858-534-8248 or by email
- Sarasota: Florida Cancer Specialists; Study PI: Dr. Judy Wang;
Contact: 941-377-9993 or by email
- Tampa: Moffitt Cancer Center; Study PI: Dr. Hyo (Heather) Han; Contact: TBD
- New York: Columbia University; Study PI: Dr. Meghna Trivedi;
Contact: Brianne Bodin or by email
- Columbus: Ohio State University; Study PI: Dr. Robert Wesolowski;
Contact: Robert Wesolowski by email
- San Antonio: South Texas Accelerated Research Therapeutics; Study PI: Dr. Muralidhar Beeram; Contact: Isabel Jimenez 210-593-5265 or by email
For more information about the study, visit https://phoenixmd.ca/clinical-trials.
Women and men with measurable metastatic triple negative breast cancer if they are:
- at least 18 years old;
- willing to provide blood and tumor tissue samples for testing;
- progression on or after standard of care therapy;
- resolved treatment related toxicity;
- adequate immune, liver, kidney function;
- no available standard of care therapy that would confer clinical benefit;
- otherwise in reasonably good health.
Women and men who have the below:
- a minimum of 14 days from prior chemotherapy, biological, or investigational therapy;
- use of medication that is known to prolong QT/QTc interval, induces CYP3A, substrate of BCRP and MATE2K;
- known history of leptomeningeal metastases;
- brain metastases, unless appropriately treated and neurologically stable;
- pregnant or breast-feeding;
- active bacterial, viral, or fungal infection(s) requiring systemic therapy including Hepatitis B, Hepatitis C, HIV+;
- other known active cancer(s);
- active gastrointestinal disease or other condition that is expected to interfere significantly with oral therapy;
- history of clinically significant cardiovascular abnormalities.