Study To Assess The Safety And Preliminary Efficacy Of STI-1386 Oncolytic Virus In Relapsed Or Refractory Solid Tumors

Study Overview

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

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.

Cancer
Cancer of Pancreas
Sarcoma
Hepatic Metastasis
Solid Tumor

DRUG: STI-1386

OV2-RRST-101

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-04-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-04-10
First Submitted that Met QC Criteria 2022-05-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-04-12
First Posted (ACTUAL) 2022-05-05	Results First Posted N/A	Last Verified 2023-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Preliminary Efficacy of STI-1386	Assess the preliminary efficacy of STI-1386 using the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)	baseline through study completion at up to approximately 29 months
Measuring Pharmacokinetic [PK] Profile	STI-1386 blood plasma concentrations will be measured	baseline through study completion at up to approximately 29 months
Assess immunoglobulin levels	Assessment of serum immunoglobulin levels	baseline through study completion at up to approximately 29 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Mike Royal, MD

Phone Number: 858-203-4100

Email: mroyal@sorrentotherapeutics.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Mike Royal, MD, Sorrento Therapeutics, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record