Sorrento Therapeutics, Inc.
This is a Phase 1b study to assess the safety and tolerability of STI-1386, an oncolytic virus, in subjects with relapsed and refractory solid tumors (RRSTs).
Cancer
Cancer of Pancreas
Sarcoma
Hepatic Metastasis
Solid Tumor
STI-1386
Phase 1
This is a Phase 1b, dose-ascending study to assess the safety, tolerability and recommended phase 2 dose (RP2D) of STI-1386 in subjects with relapsed and refractory solid tumors (RRSTs). STI-1386 is a second generation oncolytic virus. This is a two-stage study, the first stage uses a single ascending dose, followed by the multiple ascending dose stage.}}
Study Type : | Interventional |
Estimated Enrollment : | 36 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase 1b, Dose-Escalation Study of the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Patients With Relapsed or Refractory Solid Tumors |
Actual Study Start Date : | August 2023 |
Estimated Primary Completion Date : | October 2026 |
Estimated Study Completion Date : | February 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: STI-1386 A dose-escalation standard 3+3 design will be utilized and a total of 3 dosing cohorts are planned, receiving up to 4 mL of 1 x 10^6 / 1 mL, 1 x 10^7 / 1 mL, or 1 x 10^8 / 1 mL. |
Friend: STI-1386 |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.