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

An Open-labeled Phase I Clinical Trial Evaluating the Safety, Tolerability, Biodistribution Characteristics, Biological EEffects, and Initial Efficacy of VRT106 for Injection in the Treatment of Locally Advanced/Metastatic Solid Tumors by Intravenous Administration

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06826313

Enrollment

Registered

2025-02-13

Start date

2025-03-19

Completion date

2029-03-01

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

Solid Tumor, Oncolytic Virus, VRT106

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.

Interventions

BIOLOGICALVRT106

Intravenous drip administration

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. 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. 2. Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female. 3. Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment. 4. Subjects have at least one measurable lesion. 5. ECOG score of 0 to 28 days prior to first dose of IMP. 6. An expected survival time of ≥ 12 weeks. 7. Have sufficient organ function. 8. Female patients of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose of study drug. 9. 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

1. Subject has received any antitumor therapy within 4 weeks prior to the first dose of IMP. 2. Subject has previously received oncolytic virus or other gene drug therapy. 3. Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of IMP. 4. Subject is known to have an allergic reaction to any of the components of IMP. 5. Women who are breastfeeding.

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors	About 2 years	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.

Countries

China

Contacts

CONTACTThird Affiliated Hospital, Sun Yat-sen University

clinicaltrialinfo@virot.cn+86-020-32030745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026