Contact

info@syndevrx.com

1 Broadway # 14, Cambridge, MA 02142

SynDevRx is developing new therapies to improve the future of treatment for:

  • Cancers exacerbated by metabolic hormone dysfunction (i.e. metabo-oncology)

  • Other cancer types (e.g. NSCLC)

  • Other conditions associated with metabolic dysfunction (e.g. T2D, NASH)

Please see below for information on SynDevRx-sponsored clinical trials.

Latest Clinical Trials Updates

Phase 1

A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors

  • This was a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.

    Goals Achieved:

    Recommended Phase 2 dosing schedule (Q14D)
    Virtual elimination of CNS toxicity (historical class effect)
    DLT defined
    Single agent activity: reductions in metastases, stable disease
    Major improvements in key biomarkers (insulin, leptin, adiponectin, bFGF, VEGF-C, IGF-1, CRP)
    Desirable PK profile – low Cmax, high AUC
    Minimize site of injection issues (historical class effect)

    co-Founder James Shanahan discusses metabo-oncology

Status: Completed

Trial Details

Phase 1b/2

A Phase 1b/2 Study of SDX-7320 in Combination with Alpelisib and Fulvestrant to Assess Safety in Patients with Metastatic Breast Cancer with the PIK3CA Mutation

  • This is a multicenter Phase 1b/2 study to assess the safety, tolerability and efficacy of subcutaneously administered SDX-7320 in combination with the standard dose and schedule of alpelisib (PIQRAY(R)) plus fulvestrant in postmenopausal women with advanced HR+/HER2- metastatic breast cancer who have progressed after an initial treatment regimen of hormone therapy with or without a CDK4/6 targeted therapy.
  • Other selected, advanced, metabolically-sensitive solid tumor types will be considered for separate treatment arms in both men and women.

Status: Planned for H2 2019