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

NCT05361954 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: OV2-RRST-101
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

Cancer; solid tumor; hepatic metastasis

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs)

  Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)

  baseline through study completion at up to approximately 29 months

• Incidence of immune-related adverse events (IrAEs)

  Safety as assessed by incidence of IrAEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5)

  baseline through study completion at up to approximately 29 months

Secondary Outcomes (3)

• Preliminary Efficacy of STI-1386

  baseline through study completion at up to approximately 29 months

• Measuring Pharmacokinetic [PK] Profile

  baseline through study completion at up to approximately 29 months

• Assess immunoglobulin levels

  baseline through study completion at up to approximately 29 months

Study Arms (1)

STI-1386

EXPERIMENTAL

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

Interventions

STI-1386 DRUG

Second generation oncolytic virus

Also known as: Seprehvec

STI-1386

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sorrento Therapeutics, Inc.: lead

MeSH Terms

Conditions

Neoplasms; Pancreatic Neoplasms; Sarcoma

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Officials

• Mike Royal, MD

  Sorrento Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Mike Royal, MD

CONTACT

858-203-4100; mroyal@sorrentotherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 5, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 12, 2023

Record last verified: 2023-04