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

Phase 1

Not yet recruiting

• Conditions: Solid Tumors
• Interventions: Biological: VRT106

• Registration Number: NCT06826313
• Lead Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd.

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-10
• Last Update Submitted: 2025-02-10
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Study Start: 2025-03-01
• Primary Completion: 2025-12-30
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VRT106 for injection	VRT106	VRT106 will be administered through IV drip

Primary Outcome Measures

Name	Time	Method
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.