Amelia-1 Study - A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with the PI3Kα Inhibitor Alpelisib (PIQRAY®) plus Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia with Advanced Breast Cancer and a PIK3CA Mutation Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor
- The Amelia-1 Study is a multicenter Phase 1b/2 study to assess the safety, tolerability and efficacy of subcutaneously administered evexomostat (SDX-7320) in combination with alpelisib (PIQRAY(R)) plus fulvestrant (triplet therapy) in postmenopausal women at risk for hyperglycemia with advanced or metastatic HR+/HER2- breast cancer with a mutation in the PIK3CA gene who have progressed after treatment with endocrine therapy plus a CDK 4/6 inhibitor.
Status: Enrollment OpenTrial Details
A Phase II Study of Evexomostat plus Eribulin for People with Triple-Negative Breast Cancer
The purpose of this study is to assess the safety and effectiveness of adding the drug evexomostat (SDX-7320) to standard eribulin chemotherapy in people with triple-negative breast cancer (TNBC) that has come back or spread despite treatment. In addition, the participants in this study have metabolic disorders such as high blood sugar and/or obesity.
TNBC includes breast cancers do not contain receptors for estrogen or progesterone and do not have the HER2 protein, so they cannot be treated with medications that target those proteins.
Metabolic disorders, such as high blood sugar and/or obesity, can accelerate the growth of breast cancers and possibly cause resistance to standard cancer treatments. Evexomostat has been shown to slow tumor growth, improve metabolic disorders, and was safe when given by itself in earlier phase 1 trials. This study will determine whether there is a benefit to adding evexomostat to standard chemotherapy.
Status: Enrollment Open (Greater NYC)Trial Details
Phase 1 (completed)
A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
SDX-7320 is a cytostatic drug with anti-angiogenic activity and anti-metabolic activity. There was stable disease in >50% of the patients for at least the first CT scan (2 months) with the median treatment period was 6 cycles (1 cycle = 28 days). We noted significant reductions in key angiogenic markers, VEGF-C and bFGF, plus significant changes in the key metabolic markers leptin and adiponectin, and significant improvements in insulin sensitivity. These changes occurred over a broad range of doses.
Target engagement was measured in a surrogate compartment (whole blood) and was dose dependent.
Safety: SDX-7320 was generally well tolerated with thrombocytopenia being the DLT, which was reversible upon drug cessation without intervention. There was minimal site-of-injection reactions. Otherwise, toxicities were generally mild in nature (G1-G2).
We believe the safety profile makes SDX-7320 a good drug for future combination studies.
AACR 2020: SynDevRx Selected to Present the Results from its Phase 1 Study of SDX-7320 in Late-Stage Cancer Patients
Presented by Monica Mita, MD, Professor of Medicine, Co-Director, Experimental Therapeutics Program at Cedars-Sinai Medical Center Los Angeles, CA
Download the Presentation here.
Status: CompletedTrial Details
SynDevRx Expanded Access Policy
SynDevRx is a clinical-stage biotechnology company focused on developing treatments that address a serious and unmet medical need: cancers that are sensitive to dysregulated metabolic hormones. It is well established that obesity and diabetes increase the risks for developing cancer, but new research shows that these same risk factors also promote cancer and increase its lethality. Our approach combines standard of care therapies with our lead drug evexomostat (SDX-7320) to improve the tumor micro-environment by correcting the systemic metabolic hormones and key angiogenic factors that promote cancer progression and metastasis. We are the first company to target this significant yet underfunded area of research in drug development – an area called ‘metabo-oncology’.
SynDevRx has completed a Phase 1 study and is conducting 2 Phase 2 clinical studies – the first in post-menopausal HR+, Her2- metastatic breast cancer patients with the PIK3CA mutation in combination with standard of care treatment (Piqray(R) and fulvestrant). The second clinical study is in patients with triple-negative breast cancer (TNBC) and an HbA1c >5.5 or a BMI >30.
Information regarding our clinical trials can be accessed at www.clinicaltrials.gov.
In addition to our clinical trials, SynDevRx has an Expanded Access Policy for evexomostat (SDX-7320) for eligible patients in the U.S. Expanded Access refers to the use of an investigational drug by an individual patient outside of a clinical trial to prevent or treat a serious condition when the patient is unable to obtain the investigational drug under an IND (e.g., when a patient is not eligible for a clinical study or a clinical study is not recruiting or has been completed). To qualify for the SynDevRx Expanded Access Program, the patient’s physician must determine that probable risk to the patient from the investigational drug is not greater than the probable risk from the disease or condition. Expanded access is different from a clinical trial where the primary purpose is to collect extensive safety and efficacy data to support submission of an application to the U.S. Food and Drug Administration (FDA) to market a drug.
Physicians seeking additional information regarding Expanded Access for evexomostat (SDX-7320) should submit a request via email@example.com (telephone number 1-617-401-3110). SynDevRx considers providing access to our investigational drug evexomostat (SDX-7320) on a case-by-case basis, dependent on available drug supplies, the physician’s determination as to whether the potential benefit to the patient justifies the potential risks, and company resources. A requesting oncologist/physician should expect to receive a response acknowledging receipt of a request within 5 business days after a completed request has been received.
The request for access to a SynDevRx investigational medicine can only be considered if the patient’s treating physician is committed to, and supportive of, the requested treatment.
In accordance with the 21st Century Cures Act, this policy may be revised at any time. Should you have additional questions, please reach out to your oncologist/physician.