study to assess the safety and preliminary efficacy of sti-1386 oncolytic virus in relapsed or refractory solid tumors

Conditions: Cancer; Cancer of Pancreas; Sarcoma; Hepatic Metastasis; Solid Tumor

Summary: 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.

Eligibility criteria:
inclusion criteria: * 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 * adequate hematologic, liver and renal function at screening as determined by lab criteria * recovered \< grade 2 from all acute toxicities from previous therapy * has not had prior treatment with high dose corticosteroids within the 2 weeks of screening * is willing and able to comply with the study schedule and other protocol requirements * willing to follow contraception guidelines exclusion criteria: * 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 * diagnosis of other malignancies that have required therapy in the last year or are not in complete remission. exceptions include non-metastatic basal cell or squamous cell carcinomas of the skin, prostate cancer or cancer in situ that does not require treatment currently or is otherwise under control * requiring chronic systemic immunosuppressants, including steroids \> 20 mg/day * presence of bulky disease defined as any single mass \> 5 cm in greatest dimension will trigger a discussion to determine eligibility * new york heart association (nyha) class \>3 of left ventricular ejection fraction (lvef) \< 50% * prolonged corrected qt interval as determined by 12-lead electrocardiogram * has spinal cord compression or clinically unstable brain metastases within 4 weeks of first dose of study drug * evidence of active herpes infection and/or chronic herpes infection requiring prophylactic antiviral medication that may not be discontinued * has an active or recent covid-19 infection, must have a negative rt-pcr test and not have had symptoms within 4 weeks of day 1 of study drug administration * any active infection requiring systemic therapy within 72 hours of injection of sti-1386, excluding anti-viral maintenance therapy for hiv * moderate to severe chronic obstructive pulmonary disease or other moderate to severe chronic respiratory conditions unless under treatment and stable for the 3 months of screening * have active human immunodeficiency virus (hiv) infection, human t-cell leukemia virus type 1 (htlv1) infection, or hepatitis b virus (hbv) or hepatitis c virus (hcv) viremia * pregnant or lactating or up to 3 months post last dose * underlying medical conditions that, in the opinion of the investigator and/or medical monitor will prevent the subject from participating * allergy to acyclovir and related anti-hsv antiviral agents

Keywords: cancer solid tumor hepatic metastasis