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

ConditionsCancerCancer of PancreasSarcomaHepatic MetastasisSolid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSorrento Therapeutics, Inc.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • STI-1386

    Drug

    Second generation oncolytic virus

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: STI-1386Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
baseline through study completion at up to approximately 29 months
2

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)

Time frame
baseline through study completion at up to approximately 29 months

Secondary outcomes

1

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)

Time frame
baseline through study completion at up to approximately 29 months
2

Measuring Pharmacokinetic [PK] Profile

STI-1386 blood plasma concentrations will be measured

Time frame
baseline through study completion at up to approximately 29 months
3

Assess immunoglobulin levels

Assessment of serum immunoglobulin levels

Time frame
baseline through study completion at up to approximately 29 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sorrento Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: