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

This Phase 1 trial will test whether an intravenous medicine called VRT106 is safe and tolerable for adults (18–75) with locally advanced or metastatic solid tumors who have run out of standard treatment options.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06826313 on ClinicalTrials.gov

What this trial studies

Adults with histologically or cytologically confirmed locally advanced or metastatic solid tumors that are intolerant or refractory to standard systemic therapy will receive intravenous VRT106. This Phase 1, open-label dose-escalation study will escalate doses to determine the maximum tolerated dose, maximum administered dose, optimal bioavailable dose, and a recommended Phase II dose while closely monitoring safety and organ function. Key measures include adverse events, pharmacokinetics, and preliminary anti-tumor activity based on measurable lesions. The trial is being run at the Third Affiliated Hospital of Sun Yat-sen University in Guangzhou.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with measurable locally advanced or metastatic solid tumors who are intolerant of or refractory to standard systemic treatments, have ECOG 0–2, and adequate organ function.

Not a fit: Patients who are pregnant, have poor organ function or uncontrolled comorbidities, active serious infections, or who can still receive effective standard therapy are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, VRT106 could become a new systemic oncolytic therapy option that may shrink tumors or prolong disease control for patients with few other choices.

How similar studies have performed: Oncolytic viruses have demonstrated clinical benefit with local (intralesional) delivery in some cancers (e.g., T-VEC for melanoma), but intravenous systemic delivery is relatively novel and has shown limited, early-phase signals so far.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Third Affiliated Hospital, Sun Yat-sen University

Conditions: Solid Tumors, Solid Tumor, Oncolytic Virus, VRT106