NCT05361954

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sorrento Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DRUG	STI-1386	Second generation oncolytic virus

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-10-01
• Completion: 2027-02-01
• First posted: 2022-05-05
• Last updated: 2023-04-12

Regulatory

• FDA-regulated drug study