CancerPhase 1NCT05361954
Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors
A Phase 1 study testing STI-1386 in people with Cancer and Cancer of Pancreas, run by Sorrento Therapeutics, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer of Pancreas, Sarcoma
- What is being tested?
- STI-1386
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Aug 2023to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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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
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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).
Read the 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.
- Conditions
- Cancer, Cancer of Pancreas, Sarcoma, Hepatic Metastasis, Solid Tumor
- Being tested
- STI-1386
- Keywords
- Cancer, solid tumor, hepatic metastasis
- Medical subject headings
- Neoplasms, Pancreatic Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-1386Drug
Also called Seprehvec
Second generation oncolytic virus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: STI-1386 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: baseline through study completion at up to approximately 29 months
Secondary outcomes (3)
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)
Measured: baseline through study completion at up to approximately 29 months
Measuring Pharmacokinetic [PK] Profile
STI-1386 blood plasma concentrations will be measured
Measured: baseline through study completion at up to approximately 29 months
Assess immunoglobulin levels
Assessment of serum immunoglobulin levels
Measured: baseline through study completion at up to approximately 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study startAug 2023 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361954
- Sponsor's protocol ID
- OV2-RRST-101
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05361954
- Acronym / sponsor ID
- OV2-RRST-101
- Conditions
- Cancer, Cancer of Pancreas, Sarcoma, Hepatic Metastasis, Solid Tumor
- Keywords
- Cancer, solid tumor, hepatic metastasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2023 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 5 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STI-1386 | Experimental | Drug: STI-1386A 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STI-1386Also: SeprehvecSecond generation oncolytic virus | Drug | STI-1386 |
Primary outcome
Incidence of adverse events (AEs)
Time frame: 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)
Time frame: 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)
3 secondary outcomes
Preliminary Efficacy of STI-1386
Time frame: baseline through study completion at up to approximately 29 months
Measuring Pharmacokinetic [PK] Profile
Time frame: baseline through study completion at up to approximately 29 months
Assess immunoglobulin levels
Time frame: baseline through study completion at up to approximately 29 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STI-1386 in people with Cancer and Cancer of Pancreas, run by Sorrento Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mike Royal, MD (858-203-4100 ext. 4146, mroyal@sorrentotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: baseline through study completion at up to approximately 29 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.