Recent Updates
Recently added Catalysts

STI-1386

Phase 1

Cancer | Small Molecules | Oncology |Sorrento Therapeutics, Inc.|Trials Updated: Apr 12, 2023

STI-1386 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since May 2022

STI-1386 target and mechanism

ModalitySmall Molecules

Also known as Seprehvec

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

STI-1386 clinical trials

STI-1386 · 1 trial · 5 indications

Phase 1 1
NCT05361954Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid TumorsCancer
NOT YET_RECRUITING36 Analytics
PHASE1NOT YET_RECRUITING
Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors
Cancer
NCT0536195436
Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
STI-1386EXPERIMENTALA 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.

Interventions

NameTypeDescription
STI-1386DRUGSecond generation oncolytic virus
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * 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 i...

Unlock Eligibility Criteria

Competitive Landscape -Cancer 13 trials

Top 5 of 9 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN1PHASE2Durvalumab
Nanobiotix SA Sponsored ADRNBTX1PHASE1NBTXR3
Olema Oncology, Inc.OLMA1PHASE1OP-3136, Palazestrant
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
Pfizer Inc.PFE1N/APalbociclib
Unlock Competitive Intelligence

Explore more on BiopharmaWatch

Sorrento Therapeutics, Inc. (SRNE)Pipeline, catalysts, financials, insiders and newsBiotech disease mapWho is developing what in each indication, and how crowded it isFDA calendarUpcoming PDUFA dates, AdComs and approval oddsPDUFA calendarEvery scheduled FDA decision date, month by monthHistorical FDA calendarPast decisions and how the stock moved on eachCatalyst SyncUpcoming readouts and decisions, screened by runway and phaseBiotech stock screenerFilter by clinical phase, cash runway and market capDrugs A to ZEvery drug page starting with SCompanies A to ZEvery biotech and pharma company we track