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.
Recommended Phase 2 dosing schedule (Q14D)
Virtual elimination of CNS toxicity (historical class effect)
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)
Status: CompletedTrial Details
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