Solid TumorsPhase 1NCT06826313
A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing VRT106 in people with Solid Tumors, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- VRT106
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2025to 1 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
Liang Peng Principal Investigator, Ph.D; Professor, +86-13556065609, pliang@mail.sysu.edu.cn
About this study
Official title: 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
A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- VRT106
- Keywords
- Solid Tumor, Oncolytic Virus, VRT106
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRT106Biological
Intravenous drip administration
| Study group | Role | What they receive |
|---|---|---|
| VRT106 for injection | Experimental | VRT106 will be administered through IV drip Receives: Biological: VRT106 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start19 Mar 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826313
- Sponsor's protocol ID
- VRT106-CN01
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06826313
- Acronym / sponsor ID
- VRT106-CN01
- Conditions
- Solid Tumors
- Keywords
- Solid Tumor, Oncolytic Virus, VRT106
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guangzhou Virotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Third Affiliated Hospital, Sun Yat-Sen University
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRT106 for injection | Experimental | Biological: VRT106VRT106 will be administered through IV drip |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRT106Intravenous drip administration | Biological | VRT106 for injection |
Primary outcome
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRT106 in people with Solid Tumors, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Third Affiliated Hospital, Sun Yat-sen University (+86-020-32030745, clinicaltrialinfo@virot.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors (time frame: About 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.