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).
Histologically confirmed extracranial solid tumors that are relapsing or refractory including locally advanced pancreatic cancer, unresectable soft tissue sarcomas, hepatic metastases due to colorectal cancer
At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1) with a non-nodal lesion with longest diameter ≥ 10 mm or nodal lesions with short diameter ≥ 15 mm
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
As assessed by the investigator, ≥ 3 month life expectancy
Have a primary brain tumor
Use of an investigational drug or local therapy or agent within 2 weeks of first dose of study drug. Current systemic chemotherapy per investigator's discretion is allowed, but no immune checkpoint inhibitors or immune modulators
Use of anticoagulants or anti-platelet agents unless subject can safely start/stop to allow intratumoral injections
Use of bevacizumab (Avastin) within 28 days of the STI-1386 injection