NCT06889675

First in Human Study of YB1-X7 Injection

An Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of YB1-X7 Injection in Subjects with Advanced Solid Tumors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shanghai Salvectors Biotechnology LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is an open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic, and preliminary efficacy of YB1-X7 injection in subjects with advanced solid tumors. YB1-X7 injection is an attenuated Salmonella-based tumor therapy. It selectively accumulates in hypoxic tumor regions while being rapidly cleared from normal organs. After proliferating in the tumor microenvironment, YB1-X7 invades tumor cells and releases its therapeutic payload, leading to tumor cell death and tumor regression. Conditions：To treat subjects with advanced and/or metastatic solid tumors who do not to respond to conventional standard treatment or who lack effective standard treatment.

Detailed description

YB1-X7 is a genetically engineered attenuated Salmonella enterica strain. It has been further optimized based on the attenuated model of VNP20009 while inserting an anaerobic-targeting enrichment system, transforming YB1-X7 into a nutrient-deficient strain under aerobic conditions. This modification allows YB1-X7 to selective proliferation in hypoxic tumor regions while being cleared in normal oxygenated tissues, thereby achieving selective enrichment in tumor. Additionally, YB1-X7 carries plasmids encoding the drug protein. Upon reaching the tumor region, YB1-X7 invades tumor cells, expressing and releasing drug protein, leading to tumor cell death and tumor regression. This study is divided into two parts based on the route of administration: Part 1: Subjects receiving intratumoral injection (IT). Part 2: Subjects receiving intravenous infusion (IV). Both administration routes will have three dose cohorts (low, medium, and high dose) following the standard 3+3 dose-escalation design, with single-dose multiple administrations in an escalating dose scheme. Each subject will receive only one administration method (IT or IV) and be assigned to only one dose cohort, completing the full treatment regimen for that dose level. YB1-X7 injection will be administrated in 28-days cycles (once weekly for 3 weeks followed by 1-week rest). For Subjects receiving intratumoral injection, superficial lesions can be injected directly, while deep-seated lesions may require ultrasound, CT, or endoscopic guidance for precise administration.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	YB1-X7 Injection (IT)	Intratumoral injection
DRUG	YB1-X7 Injection (IV)	Intravenous infusion

Timeline

• Start date: 2025-03-15
• Primary completion: 2027-01-31
• Completion: 2027-03-31
• First posted: 2025-03-21
• Last updated: 2025-03-21