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
Trial ID: NCT05361954
Interventional - Phase 1 - Not yet recruiting
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).
Conditions
- Cancer
- Cancer of Pancreas
- Sarcoma
- Hepatic Metastasis
- Solid Tumor
Interventions
Eligibility
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
Sponsor
Sorrento Therapeutics, Inc.
Source: Clinicaltrials.gov
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