Solid TumorPhase 1NCT06046742
A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing M1-c6v1 in people with Solid Tumor, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 3 sites in Japan.
Trial summary
A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- M1-c6v1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesJapan
- Study dates
- 10 Jul 2024to 20 Dec 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females at least 18 years of age, inclusive, at the Screening Visit.
- Have at least one measurable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
- An estimated survival time of ≥ 12 weeks.
Who cannot join
- Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
- Subject has received systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba
Dr. Kojima Takashi, M.D., +81-4-7133-1111, clinicaltrialinfo@virot.cn
- Recruiting
St. Marianna University Hospital
Kawasaki-shi, Kanagawa
Dr. Sunakawa, Yu, M.D., clinicaltrialinfo@virot.cn
- Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime
Dr. Nishina Tomohiro, M.D., +81-89-999-1111, clinicaltrialinfo@virot.cn
About this study
Official title: A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
Read the detailed description
This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.
- Conditions
- Solid Tumor
- Being tested
- M1-c6v1
- Keywords
- M1-c6v1, Solid Tumor, Oncolytic Virus, VRT106
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M1-c6v1Biological
Intravenous drip administration
| Study group | Role | What they receive |
|---|---|---|
| M1-c6v1 intravenous injection | Experimental | M1-c6v1 will be administered through IV drip Receives: Biological: M1-c6v1 |
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 intravenous M1-c6v1 in Patients with advanced malignant tumors
Monitor the incidence of adverse events (TEAEs) during the study.
Measured: About 2 years
Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1.
Incidence of DLT
Measured: About 2 years
Conduct a dose extension study to evaluate the safety and tolerability of intravenous administration of M1-c6v1 at maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
Monitor the incidence of adverse events (TEAEs) during the study.
Measured: About 2 years
Secondary outcomes (3)
Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1.
Measure the distribution and shedding of M1-c6v1 following intravenous injection by detecting its presence in blood, saliva, urine, nasal swabs, and feces using qPCR (quantitative polymerase chain reaction) method.
Measured: About 2 years
Assess the immunogenicity of intravenous administration of M1-c6v1.
Detect the presence of neutralizing antibodies against M1-c6v1 and assess their titers, which represent the potency of the neutralizing antibodies, using the PD50 value.
Measured: About 2 years
Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators.
Based on the specific tumor types, assess the ORR (Objective Response Rate) and DCR (Disease Control Rate) using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 or mRECIST (modified Response Evaluation Criteria in Solid Tumors) criteria.
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 posted21 Sep 2023
- Study start10 Jul 2024
- Primary completion30 Jun 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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)
- Responsible party
- Sponsor
- Investigators
- Guangzhou Virotech Pharmaceutical Co., Ltd., Study chair, Guangzhou Virotech Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046742
- Sponsor's protocol ID
- VRT106-J01
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06046742
- Acronym / sponsor ID
- VRT106-J01
- Conditions
- Solid Tumor
- Keywords
- M1-c6v1, 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)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 21 Sep 2023 (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 M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors
Detailed description
This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| M1-c6v1 intravenous injection | Experimental | Biological: M1-c6v1M1-c6v1 will be administered through IV drip |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
- Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females at least 18 years of age, inclusive, at the Screening Visit.
- Have at least one measurable lesion.
- An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
Key exclusion criteria (4 listed)
- Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
- Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
- Subject has received systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.
- Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.
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 |
|---|---|---|
| M1-c6v1Intravenous drip administration | Biological | M1-c6v1 intravenous injection |
Primary outcome
Evaluate the safety and tolerability of escalating doses of intravenous M1-c6v1 in Patients with advanced malignant tumors
Time frame: About 2 years
Monitor the incidence of adverse events (TEAEs) during the study.
Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1.
Time frame: About 2 years
Incidence of DLT
Conduct a dose extension study to evaluate the safety and tolerability of intravenous administration of M1-c6v1 at maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
Time frame: About 2 years
Monitor the incidence of adverse events (TEAEs) during the study.
3 secondary outcomes
Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1.
Time frame: About 2 years
Assess the immunogenicity of intravenous administration of M1-c6v1.
Time frame: About 2 years
Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators.
Time frame: About 2 years
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 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Guangzhou Virotech Pharmaceutical Co., Ltd. study chair
Guangzhou Virotech Pharmaceutical Co., Ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M1-c6v1 in people with Solid Tumor, run by Guangzhou Virotech Pharmaceutical Co., Ltd. at 3 sites in Japan.
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 6 inclusion and 4 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 11 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 3 sites in Japan. 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 Guangzhou Virotech Pharmaceutical Co., Ltd. (+86-020-32030725, 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 intravenous M1-c6v1 in Patients with advanced malignant tumors (time frame: About 2 years). The study lists 3 primary outcomes in all. 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 11 Sep 2026.