A Study of Intravenous VRT106 for Locally Advanced or Met... | NCT06826313

Studies
A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors

NCT06826313

Sponsor

Guangzhou Virotech Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Jul 18, 2025Actual

Enrollment

12Estimated

Phase

Phase 1

Conditions

Solid Tumors

Interventions

VRT106

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2025Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Mar 1, 2027Estimated

First Submitted Date

Feb 10, 2025

First Submission Date that Met QC Criteria

Feb 10, 2025

First Posted Date

Feb 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2025

Last Update Posted Date

Jul 18, 2025Actual

Name	Class
Third Affiliated Hospital, Sun Yat-Sen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors

Detailed Description

To evaluate VRT106 for injection in patients with locally advanced/metastatic solid tumours for safety and tolerability, exploring the maximum tolerated dose (MTD)/maximum administered dose (MAD)/optimal bioavailable dose (OBD) and/or the recommended phase II clinical dose (RP2D) to provide a recommended dose for subsequent clinical trials.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VRT106 for injection	Experimental	VRT106 will be administered through IV drip	Biological: VRT106

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VRT106	Biological	Intravenous drip administration	VRT106 for injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors	To evaluate the safety and tolerability of VRT106 in patients with locally advanced/metastatic solid tumours and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose (RP2D), which will provide a recommended dose for subsequent clinical trials.	About 2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.
Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female.
Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment.
Subjects have at least one measurable lesion.
ECOG score of 0 to 28 days prior to first dose of IMP.
An expected survival time of ≥ 12 weeks.
Have sufficient organ function.
Female patients of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose of study drug.
Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.

Exclusion Criteria:

Subject has received any antitumor therapy within 4 weeks prior to the first dose of IMP.
Subject has previously received oncolytic virus or other gene drug therapy.
Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of IMP.
Subject is known to have an allergic reaction to any of the components of IMP.
Women who are breastfeeding.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Third Affiliated Hospital, Sun Yat-sen University	Contact	+86-020-32030745		clinicaltrialinfo@virot.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Third Affiliated Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510000	China