Advanced Solid TumorPhase 1/2NCT05602792
A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
A Phase 1/2 study testing T3011 in people with Advanced Solid Tumor and Sarcoma, run by ImmVira Pharma Co. Ltd at 19 sites in China.
Trial summary
A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Sarcoma, HNSCC
- What is being tested?
- T3011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 19 sitesChina
- Study dates
- 21 Apr 2020to Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- 1. Age 18~70 years Part I ; Age 18 years or older (Part II and III ). 2. Histologically or pathologically confirmed diagnosis of locally recurrent or metastatic advanced malignancy.
- 3. Measurable disease per RECIST version 1.1. 4. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Life expectancy > 12 weeks. 7. Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011.
- 8. WCBP must have a negative serum pregnancy test Within 7 days prior to W1D1. 9. Capable of understanding and complying with protocol requirements.
Who cannot join
- 1. Last dose of previous anticancer therapy < 4 weeks. 2. Prior treatment with another oncolytic virus or gene therapy. 3. Previous intolerance to anti-PD-(L)1 monoclonal antibody or previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease.
- 4. History of seizure disorders within 12 months of Screening. 5.History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
- 6. Requires continued concurrent therapy with any drug active against HSV. 7. Pregnant or lactating.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites, 19 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Li Hang, Professor, 010-83572211, clinicaltrials@immviragroup.com
- Recruiting
Beijing Jishuitan Hospital
Beijing, 100035
Niu Xiaohui, Professor, 010-58516688, clinicaltrials@immviragroup.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Huang Gang, Professor, 0731-88651900, clinicaltrials@immviragroup.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Deng Yaotiao, Professor, 028-85422114, clinicaltrials@immviragroup.com
- Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong, 528406
Wang Siyang, Professor, 0756-2528888, clinicaltrials@immviragroup.com
- Recruiting
The First Affiliated Hospital of Zhejiang University Medical College
Hanzhou, Zhejiang, 310003
Zheng Yulong, Professor, 0571-87236114, clinicaltrials@immviragroup.com
- Recruiting
Zhejiang Provincial People's Hospital
Hanzhou, Zhejiang, 314408
Tong Xiangmin, Professor, 0571-87666666, clinicaltrials@immviragroup.com
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
Wang Gang, Professor, 0551-62283114, clinicaltrials@immviragroup.com
- Recruiting
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Chen Zhendong, Professor, 0551-63869420, clinicaltrials@immviragroup.com
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Tao Zhiwei, Professor, 0791-88313632, clinicaltrials@immviragroup.com
- Recruiting
Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine
Shanghai, 200011
Zhang Chenping, 23271699 ext. 5818, clinicaltrials@immviragroup.com
- Recruiting
Fudan University Cancer Hospital
Shanghai, 200032
Ji Dongmei, Professor, 021-64175590, clinicaltrials@immviragroup.com
- Recruiting
Zhongshan Hospital
Shanghai, 200032
Zhou Yuhong, Professor, 021-64041990, clinicaltrials@immviragroup.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai, 200233
Shen Zan, Professor, 021-64369181, clinicaltrials@immviragroup.com
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Li Zhendong, Professor, 024-31916684, clinicaltrials@immviragroup.com
- Recruiting
The Second People's Hospital of Shenzhen
Shenzhen, 518025
Liu Guowen, Professor, 0755-88698000, clinicaltrials@immviragroup.com
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei, 430022
Chen Jing, Professor, 027-85726114, clinicaltrials@immviragroup.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yao Weitao, Professor, 400-0371818, clinicaltrials@immviragroup.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wang Feng, Professor, 0371-67966266, clinicaltrials@immviragroup.com
About this study
Official title: A Phase I/IIa Study to Assess the Safety, Tolerability, Biodistribution and Pharmacodynamic of T3011 Herpes Virus Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors.
A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors
Read the detailed description
This is a Phase I/IIa, open-label, first-in-human study of T3011 given via intratumoral (IT) injection in participants with advanced or metastatic solid tumors. Part I and part II of the study is a dose escalation which will use a 3+3 design to evaluate escalating doses of T3011. Part I is a single dose escalation. Part II is multiple dose escalation. Total enrollment will depend on the toxicities and/or activity observed, with approximately 8-48 evaluable participants enrolled.
Once the RP2D is established ,Part III will enroll approximately 40-60 participants with sarcoma , approximately 10-25 participants with Malignant head and neck tumor,approximately 10-25 participants with breast cancer,approximately 10-25 participants with esophagus cancer,approximately 10-25 participants with lung cancer and approximately 10-25 participants with non-melanoma skin cancer.
- Conditions
- Advanced Solid Tumor, Sarcoma, HNSCC, Breast Cancer, Esophagus Cancer, NSCLC
- Being tested
- T3011
- Keywords
- Oncolytic virus, Herpes virus
- Medical subject headings
- Sarcoma, Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3011Biological
T3011 will be administered through intratumoral injection in patients with advanced solid tumors.
T3011Biological
T3011 will be administered through intratumoral injection in patients with sarcoma.
T3011Biological
T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.
T3011Biological
T3011 will be administered through intratumoral injection in patients with breast cancer.
T3011Biological
T3011 will be administered through intratumoral injection in patients with esophagus cancer.
T3011Biological
T3011 will be administered through intratumoral injection in patients with lung cancer.
T3011Biological
T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.
| Study group | Role | What they receive |
|---|---|---|
| T3011 Herpes Virus Injection | Experimental | Not described Receives: Biological: T3011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
In part I and part II, Evaluate the safety and tolerability of escalating doses of single dose and multiple dose IT T3011.Characterize DLTs and identify the MTD of IT T3011.
Incidence rate of TEAE; Incidence rate of DLT
Measured: Up to 2 years from first dose of T3011
In part III, Evaluate the safety of multiple dose IT T3011 in the following indications,including sarcoma, Malignant head and neck tumor, breast cancer, esophagus cancer, lung cancer and non-melanoma skin cancer.
Incidence rate of TEAE;
Measured: Up to 2 years from first dose of T3011
Secondary outcomes (8)
In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.
The changes of PD-1 and IL-12 concentration after administration
Measured: Up to 2 years from first dose of T3011
In part I and part II, Evaluation of pharmacodynamics of T3011
IFN-γ、 IL-1β、 IL-2、 IL-4、 IL-6、 IL-8、 IL-10、 IL-13、 TNF-α
Measured: Up to 2 years from first dose of T3011
In part I and part II, Evaluation of immunogenicity of T3011
ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1
Measured: Up to 2 years from first dose of T3011
Overall response rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST.
Measured: Up to 2 years from first dose of T3011
Disease control rate (DCR)
DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST.
Measured: Up to 2 years from first dose of T3011
Duration of response (DOR)
DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first.
Measured: Up to 2 years from first dose of T3011
Progression-free survival (PFS)
PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST.
Measured: Up to 2 years from first dose of T3011
In part III,Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause.
Measured: Up to 2 years from first dose of T3011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start21 Apr 2020
- Primary completionJul 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 233 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmVira Pharma Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602792
- Sponsor's protocol ID
- TG1819ONC
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ji D, Fu W, Liu Y, Shen W, Kuang M, Ning Z, Sang Y, Chen G, Zhang J, Zhou Z, Xu D, Jin X, Wu J, Zhou X, Zhao J, Wang L, Liu Y, Zhang X, Yan R, Chen X, Zhou G, Niu J, Hu X. First-in-human phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via intratumoral (IT) injection as monotherapy in advanced solid tumors, including recurrent or metastatic HNSCC. BMC Med. 2026 Feb 20;24(1):177. doi: 10.1186/s12916-026-04695-1.
PubMed 41721376
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Assess the Safety, Tolerability, Biodistribution and Pharmacodynamic of T3011 Herpes Virus Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT05602792
- Acronym / sponsor ID
- TG1819ONC
- Conditions
- Advanced Solid Tumor, Sarcoma, HNSCC, Breast Cancer, Esophagus Cancer, NSCLC
- Keywords
- Oncolytic virus, Herpes virus
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 233 participants (estimated)
- Lead sponsor
- ImmVira Pharma Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 2 Nov 2022 (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/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors
Detailed description
This is a Phase I/IIa, open-label, first-in-human study of T3011 given via intratumoral (IT) injection in participants with advanced or metastatic solid tumors. Part I and part II of the study is a dose escalation which will use a 3+3 design to evaluate escalating doses of T3011. Part I is a single dose escalation. Part II is multiple dose escalation. Total enrollment will depend on the toxicities and/or activity observed, with approximately 8-48 evaluable participants enrolled.
Once the RP2D is established ,Part III will enroll approximately 40-60 participants with sarcoma , approximately 10-25 participants with Malignant head and neck tumor,approximately 10-25 participants with breast cancer,approximately 10-25 participants with esophagus cancer,approximately 10-25 participants with lung cancer and approximately 10-25 participants with non-melanoma skin cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T3011 Herpes Virus Injection | Experimental | Biological: T3011 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Age 18~70 years Part I ; Age 18 years or older (Part II and III ). 2. Histologically or pathologically confirmed diagnosis of locally recurrent or metastatic advanced malignancy.
- 3. Measurable disease per RECIST version 1.1. 4. Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 6. Life expectancy > 12 weeks. 7. Women of child-bearing potential (WCBP) and men must agree to use adequate contraception prior to study entry, while on study treatment, and for six months after receiving last dose of T3011.
- 8. WCBP must have a negative serum pregnancy test Within 7 days prior to W1D1. 9. Capable of understanding and complying with protocol requirements.
Key exclusion criteria (3 listed)
- 1. Last dose of previous anticancer therapy < 4 weeks. 2. Prior treatment with another oncolytic virus or gene therapy. 3. Previous intolerance to anti-PD-(L)1 monoclonal antibody or previous history of immunotherapy induced non-infectious pneumonitis/interstitial lung disease.
- 4. History of seizure disorders within 12 months of Screening. 5.History of allergic reactions attributed to compounds of similar biological composition to HSV-1, IL-12, or anti-PD-1 monoclonal antibody.
- 6. Requires continued concurrent therapy with any drug active against HSV. 7. Pregnant or lactating.
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 |
|---|---|---|
| T3011T3011 will be administered through intratumoral injection in patients with advanced solid tumors. | Biological | T3011 Herpes Virus Injection |
| T3011T3011 will be administered through intratumoral injection in patients with sarcoma. | Biological | T3011 Herpes Virus Injection |
| T3011T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor. | Biological | T3011 Herpes Virus Injection |
| T3011T3011 will be administered through intratumoral injection in patients with breast cancer. | Biological | T3011 Herpes Virus Injection |
| T3011T3011 will be administered through intratumoral injection in patients with esophagus cancer. | Biological | T3011 Herpes Virus Injection |
| T3011T3011 will be administered through intratumoral injection in patients with lung cancer. | Biological | T3011 Herpes Virus Injection |
| T3011T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer. | Biological | T3011 Herpes Virus Injection |
Primary outcome
In part I and part II, Evaluate the safety and tolerability of escalating doses of single dose and multiple dose IT T3011.Characterize DLTs and identify the MTD of IT T3011.
Time frame: Up to 2 years from first dose of T3011
Incidence rate of TEAE; Incidence rate of DLT
In part III, Evaluate the safety of multiple dose IT T3011 in the following indications,including sarcoma, Malignant head and neck tumor, breast cancer, esophagus cancer, lung cancer and non-melanoma skin cancer.
Time frame: Up to 2 years from first dose of T3011
Incidence rate of TEAE;
8 secondary outcomes
In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.
Time frame: Up to 2 years from first dose of T3011
In part I and part II, Evaluation of pharmacodynamics of T3011
Time frame: Up to 2 years from first dose of T3011
In part I and part II, Evaluation of immunogenicity of T3011
Time frame: Up to 2 years from first dose of T3011
Overall response rate (ORR)
Time frame: Up to 2 years from first dose of T3011
Disease control rate (DCR)
Time frame: Up to 2 years from first dose of T3011
Duration of response (DOR)
Time frame: Up to 2 years from first dose of T3011
Progression-free survival (PFS)
Time frame: Up to 2 years from first dose of T3011
In part III,Overall Survival (OS)
Time frame: Up to 2 years from first dose of T3011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 41721376Ji D, Fu W, Liu Y, Shen W, Kuang M, Ning Z, Sang Y, Chen G, Zhang J, Zhou Z, Xu D, Jin X, Wu J, Zhou X, Zhao J, Wang L, Liu Y, Zhang X, Yan R, Chen X, Zhou G, Niu J, Hu X. First-in-human phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via intratumoral (IT) injection as monotherapy in advanced solid tumors, including recurrent or metastatic HNSCC. BMC Med. 2026 Feb 20;24(1):177. doi: 10.1186/s12916-026-04695-1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing T3011 in people with Advanced Solid Tumor and Sarcoma, run by ImmVira Pharma Co. Ltd at 19 sites 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ImmVira Pharma Co. LTD (781-718-5121, clinicaltrials@immviragroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In part I and part II, Evaluate the safety and tolerability of escalating doses of single dose and multiple dose IT T3011.Characterize DLTs and identify the MTD of IT T3011. (time frame: Up to 2 years from first dose of T3011). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602792, which also lists 1 linked publication.
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 2 Nov 2022.