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).
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Second generation oncolytic virus
Incidence of adverse events (AEs)
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Time frame: baseline through study completion at up to approximately 29 months
Incidence of immune-related adverse events (IrAEs)
Safety as assessed by incidence of IrAEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Time frame: baseline through study completion at up to approximately 29 months
Preliminary Efficacy of STI-1386
Assess the preliminary efficacy of STI-1386 using the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Time frame: baseline through study completion at up to approximately 29 months
Measuring Pharmacokinetic [PK] Profile
STI-1386 blood plasma concentrations will be measured
Time frame: baseline through study completion at up to approximately 29 months
Assess immunoglobulin levels
Assessment of serum immunoglobulin levels
Time frame: baseline through study completion at up to approximately 29 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.