Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors

Launched by SORRENTO THERAPEUTICS, INC. · May 2, 2022

Keywords

ClinConnect Summary

This clinical trial, called the STI-1386 study, is looking at a new treatment called an oncolytic virus for patients with certain types of cancer that have come back after treatment or have not responded to other therapies. The trial is currently not recruiting participants, but it will focus on people aged 65-74 with solid tumors, including advanced pancreatic cancer and soft tissue sarcomas. To be eligible, participants must have confirmed cancer that can be measured, a good performance status, and a life expectancy of at least three months, among other health criteria.

Participants in this study can expect to receive the STI-1386 treatment to see how safe it is and if it helps their cancer. They will need to follow specific guidelines and may have to stop certain medications before joining the trial. The study will not accept individuals with certain health conditions, active infections, or those who are pregnant or breastfeeding. This trial is an important step in exploring new ways to treat challenging cancers, and it aims to gather valuable information on the safety and early effectiveness of this new therapy.

Gender

ALL

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