Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: STI-1386 A dose-escalation standard 3+3 design will be utilized and a total of 3 dosing cohorts are planned, receiving up to 4 mL of 1 x 10^6 / 1 mL, 1 x 10^7 / 1 mL, or 1 x 10^8 / 1 mL. |
Drug: STI-1386
Second generation oncolytic virus
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events (AEs) [baseline through study completion at up to approximately 29 months]
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
- Incidence of immune-related adverse events (IrAEs) [baseline through study completion at up to approximately 29 months]
Safety as assessed by incidence of IrAEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)
Secondary Outcome Measures
- Preliminary Efficacy of STI-1386 [baseline through study completion at up to approximately 29 months]
Assess the preliminary efficacy of STI-1386 using the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
- Measuring Pharmacokinetic [PK] Profile [baseline through study completion at up to approximately 29 months]
STI-1386 blood plasma concentrations will be measured
- Assess immunoglobulin levels [baseline through study completion at up to approximately 29 months]
Assessment of serum immunoglobulin levels
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
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As assessed by the investigator, ≥ 3 month life expectancy
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Adequate hematologic, liver and renal function at Screening as determined by lab criteria
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Recovered < Grade 2 from all acute toxicities from previous therapy
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Has not had prior treatment with high dose corticosteroids within the 2 weeks of screening
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Is willing and able to comply with the study schedule and other protocol requirements
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Willing to follow contraception guidelines
Exclusion Criteria:
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Have a primary brain tumor
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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
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Use of anticoagulants or anti-platelet agents unless subject can safely start/stop to allow intratumoral injections
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Use of bevacizumab (Avastin) within 28 days of the STI-1386 injection
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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
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Requiring chronic systemic immunosuppressants, including steroids > 20 mg/day
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Presence of bulky disease defined as any single mass > 5 cm in greatest dimension will trigger a discussion to determine eligibility
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New York Heart Association (NYHA) Class >3 of left ventricular ejection fraction (LVEF) < 50%
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Prolonged corrected QT interval as determined by 12-lead electrocardiogram
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Has spinal cord compression or clinically unstable brain metastases within 4 weeks of first dose of study drug
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Evidence of active herpes infection and/or chronic herpes infection requiring prophylactic antiviral medication that may not be discontinued
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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
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Any active infection requiring systemic therapy within 72 hours of injection of STI-1386, excluding anti-viral maintenance therapy for HIV
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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
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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
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Pregnant or lactating or up to 3 months post last dose
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Underlying medical conditions that, in the opinion of the investigator and/or medical monitor will prevent the subject from participating
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Allergy to acyclovir and related anti-HSV antiviral agents
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sorrento Therapeutics, Inc.
Investigators
- Study Director: Mike Royal, MD, Sorrento Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OV2-RRST-101