Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Infections

Digestive System Diseases

Rare Diseases

Breast Neoplasms

Herpes Simplex

Sarcoma

Virus Diseases

Skin Neoplasms

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Soft Tissue Sarcoma

T3011 will be administered through intratumoral injection in patients with advanced solid tumors.

T3011

T3011 will be administered through intratumoral injection in patients with sarcoma.

T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.

T3011 will be administered through intratumoral injection in patients with breast cancer.

T3011 will be administered through intratumoral injection in patients with esophagus cancer.

T3011 will be administered through intratumoral injection in patients with lung cancer.

T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.

ImmVira Pharma Co. LTD

Wang Gang, Professor

Chen Zhendong, Professor

Wang Siyang, Professor

Yao Weitao, Professor

Wang Feng, Professor

Chen Jing, Professor

Huang Gang, Professor

Tao Zhiwei, Professor

Li Zhendong, Professor

Deng Yaotiao, Professor

Zheng Yulong, Professor

Tong Xiangmin, Professor

Li Hang, Professor

Niu Xiaohui, Professor

Zhang Chenping

Ji Dongmei, Professor

Zhou Yuhong, Professor

Shen Zan, Professor

Liu Guowen, Professor

A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors

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.

A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors

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.

Assesse histological changes by immunohistochemical fluorescence detection

Incidence rate of TEAE; Incidence rate of DLT

The changes of PD-1 and IL-12 concentration after administration

IFN-γ、 IL-1β、 IL-2、 IL-4、 IL-6、 IL-8、 IL-10、 IL-13、 TNF-α

ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1

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.

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.

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.

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.

OS is defined as the time from enrollment to death from any cause.

ImmVira Pharma Co. Ltd

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Carcinoma

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Ependymoma

Rhabdoid Tumor

Gliosarcoma

Supratentorial Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Germ Cells Tumors

Choroid Plexus Carcinoma

Anaplastic Astrocytoma

Neuroepithelioma

All Drugs and Chemicals

Immunomodulating Agents

Single dose of HSV-1 (G207) infused through catheters into region(s) of tumor defined by MRI. If G207 is safe in the first two cohorts of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor defined by MRI followed by a 5 Gy dose of radiation to the tumor given with 24 hours of virus inoculation.

Intervention: Biological: G207

Single dose of HSV-1 (G207) infused through catheters into region(s) of tumor defined by MRI

G207

Gregory K Friedman, M.D.

This study is a clinical trial to determine the safety of injecting G207 (a new experimental virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication and tumor cell killing, will also be tested.

Outcomes for children with recurrent or progressive supratentorial malignant brain tumors are very poor, and there are a lack of effective salvage therapies once a patient fails standard treatments.

G207 is an oncolytic herpes simplex virus-1 (HSV) that has been successfully engineered to introduce mutations in the virus that enable it to selectively replicate in and kill cancer cells, but not normal cells. Replication of G207 in the tumor not only kills the infected tumor cells, but causes the tumor cell to act as a factory to produce new virus. These virus particles are released as the tumor cell dies, and can then proceed to infect other tumor cells in the vicinity, and continue the process of tumor kill. In addition to this direct oncolytic activity, the virus engenders an anti-tumor immune response; the virus is immunogenic and produces a debris field which exposes cancer cell antigens to immune cells which can target other cancer cells. Thus, the oncolytic effect of the virus and the immune response that the virus stimulates provide a one-two punch at attacking cancer cells. In preclinical studies, a single 5 Gy dose of radiation within 24 hours of virus inoculation to the tumor increased virus replication and tumor cell killing.

The University of Alabama at Birmingham has conducted three phase I trials of G207 injected into the recurrent tumor alone or combined with a single dose of radiation in adults with recurrent high-grade gliomas. In these trials, high doses (up to 3 x 10\^9 plaque-forming units) of virus were safely injected directly into the tumor or surrounding brain tissue without serious toxicities. A maximum tolerated dose was not reached in all 3 trials. Radiographic and neuropathologic evidence of an antitumor response was seen in some patients. Preclinical laboratory studies have demonstrated that a variety of aggressive pediatric brain tumor types are sensitive to G207.

This study is a phase I, open-label, single institution clinical trial of G207 alone or combined with a single low dose of radiation in children with recurrent or progressive supratentorial brain tumors. The primary goal is to determine safety. The secondary aims are to obtain preliminary information on the effectiveness of and immune response to G207.

A traditional 3 + 3 design will be used with four patient cohorts. The first two cohorts will receive G207 at one of two doses, and the second two cohorts will receive G207 at one of two doses followed by a 5 Gy dose of radiation.

HSV G207 Alone or With a Single Radiation Dose in Children With Progressive or Recurrent Supratentorial Brain Tumors

Phase I Clinical Trial of HSV G207 Alone or With a Single Radiation Dose in Children With Recurrent Supratentorial Brain Tumors

All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to G207.

HSV-1 antibody titers will be checked by ELISA prior to the administration of G207 and at regular intervals after treatment.

Saliva, blood and conjunctival secretions will be checked by polymerase chain reaction (PCR) and culture at regular intervals for evidence of HSV shedding and/or viremia.

Time after G207 administration to clinical and radiographic disease progression will be evaluated.

The overall survival for each patient receiving G207 will be calculated.

A modified Lansky score (for children under 16 years of age) or Karnofsky score (for children 16 and older) will be recorded and measured serially with the pre-treatment score.

Quality of life will be measured with questionnaires taken at baseline (before administration of G207) and at specified times thereafter.

Food and Drug Administration (FDA)

National Center for Advancing Translational Sciences of the National Institutes of Health

Cannonball Kids' Cancer Foundation

Rally Foundation for Childhood Cancer Research

Hyundai Hope On Wheels

St. Baldrick's Foundation

United States Department of Defense

Andrew McDonough B+ Foundation

Kaul Pediatric Research Institute

NIH/National Cancer Institute Cancer Center Support Grants to the University of Alabama at Birmingham

Memorial Sloan Kettering Cancer Center

Kelsie's Crew

Eli's Block Party Childhood Cancer Foundation

Eli Jackson Foundation

Jaxon's F.R.O.G. Foundation

Battle for a Cure Foundation

Sandcastle Kids

Gregory K. Friedman, MD

Principal investigator

G207, an oncolytic virus

This clinical trial will study the safety and effectiveness of an engineered herpes virus, G207, administered directly into the brain of patients with recurrent brain cancer. G207 has been modified from the herpes virus that causes cold sores (called herpes simplex virus type 1 or HSV-1). G207 has been designed so that it should kill tumor cells, but not harm normal brain cells. G207 has been shown to be safe in animal testing completed to date and in previous studies in patients with brain tumors.

This is a phase Ib/II study. In the phase Ib portion of the study, patients will receive G207 at a dose that is higher than tested in previous human studies. Patients will initially receive 15% of the assigned dose injected directly into the brain tumor. Approximately two days later, as much of the tumor as possible will be surgically removed, and more G207 will be injected into the brain tumor bed. Patients will be monitored, and medical tests will be done at specific study timepoints.

The phase II portion will begin only if there are no safety concerns in the phase Ib portion. The goals of the phase II portion of the study are to determine the safety of G207 and to study patient survival at six months after G207 dosing. In the phase II portion of the study, patients will receive a single dose of G207 at the highest dose determined to be safe in the phase Ib portion of the study. The tumor will be removed, and G207 will be injected into any remaining tumor tissue in the brain tumor bed. Patients will be closely monitored, medical tests will be performed at specific study visits, and survival will be evaluated.

Protocol NG1-003 is an open-label, phase Ib/II study of the safety and efficacy of G207, a genetically engineered herpes simplex type-1 virus. Up to 21 patients will be enrolled in the phase Ib portion and will receive doses of G207 that are higher than tested in the previous trials. The highest G207 dose tested in a previous phase I trial (NG1-001) was 3E9 plaque forming units (pfu). G207 was generally well tolerated and safe in NG1-001, and there was no dose-limiting toxicity. Patients' deaths were due to progressive cancer disease except for one (due to radiation necrosis), and two patients remain alive today.

Patients in the phase Ib portion of NG1-003 will receive G207 in divided doses. Initially, 15% of the assigned dose will be injected into the tumor. Two days later, the tumor will be removed, and the assigned dose of G207 will be injected into the tumor bed at the time of resection. The assigned doses are as follows: 1E9, 3E9, and 1E10 pfu. Patient status will be followed by MRI, Karnofsky performance, neurologic examination and the presence of G207 virus in the body, in addition to other medical tests done at specific study visits.

The phase II portion of protocol NG1-003 is a two-stage study. The phase II portion will begin only if there are no safety concerns in the phase Ib portion. The goals are to determine the safety of G207 and survival at six months. Enrollment of up to 14 patients is planned for stage one. Additional patients will be enrolled (up to 30 additional patients and 44 overall) in stage II if at least 6 of the 14 patients in stage 1 survive 6 months or longer. Participants in phase II will receive a single dose of G207 at the highest dose determined to be safe from phase Ib. G207 will be injected into the tumor bed at the time of resection. Again, patient status will be followed as previously described and survival will be evaluated.

Safety and Effectiveness Study of G207, a Tumor-Killing Virus, in Patients With Recurrent Brain Cancer

An Open-Label Phase Ib/II Study of the Safety, Tolerability and Efficacy of G207, a Genetically Engineered Herpes Simplex Type-1 Virus, Administered Intracerebrally to Patients With Recurrent Malignant Glioma

MediGene

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Lung Neoplasms

Lymphoma

Liver Neoplasms

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Mesothelial

Lymphosarcoma

Malignant Mesothelioma

T3011 will be administered through IV drip

Wang Junbin, Professor

Zhang Jian, Professor

Zhang Zhiye, Professor

Luo Suxia, M.D.

Zhang Shuang, professor

Hu Ying, M.D.

Lu Shun, Professor

This is a multicenter, open-label study conducted in 3 phases:

Dose escalation stage: The stage contain 4 cohorts, each cohort divided into 2 groups （group A, single dose and Group B, multiple dose）.Dose escalation will use a 3+3 design to evaluate escalating doses of T3011.Cohorts of three subjects will be enrolled at each T3011 dose level with expansion to six subjects, if necessary, to assess toxicity. Total enrollment will depend on the toxicities observed, with approximately 4-24 evaluable subjects enrolled in dose escalation stage.

Dose extension stage: The SMC will evaluate the available safety and preliminary efficacy data and initiate dose-expansion studies for the appropriate indications Phase IIa: To explore the safety of intravenous administration and expand the study in other indications. the stage will be carried out gradually based on the data obtained from the phase I study.

This is a multicenter, open-label study conducted in 3 phases:

Dose escalation stage: The stage contains 4 cohorts, divided into cohort 1 (1x106PFU/ dose), cohort 2 (1x107PFU/ dose), cohort 3 (1x108PFU/ dose) and cohort 4 (3x108PFU/ dose). Each cohort divided into 2 groups （group A, single dose and Group B, multiple dose）.Dose escalation will use a 3+3 design to evaluate escalating doses of T3011. At any dose level, if no DLT occurs among the first 3 subjects, then escalation to the next dose level may proceed, with the approval of the SMC. If 1 DLT occurs in the first 1 to 3 subjects, the dose level will expand to a maximum of 6 subjects. If no DLT occurs among the additional subjects, then escalation to the next dose level may proceed, with the approval of the SMC. If 2 or more DLTs occur within a cohort, then that dose level will be above the maximum tolerated dose (MTD) (the highest dose where no more than 1 of 6 subjects has experienced a DLT), and new subjects will be enrolled at the previous lower (tolerated) dose level until that cohort has 6 subjects. This lower dose level will be considered the MTD if ≤ 1 in 6 subjects has a DLT. At the end of dose escalation, the SMC will recommend a dose (the recommended phase 2 dose \[RP2D\]) of T3011 to be used in phase 2a expansion study based upon MTD identification, cumulative safety, pharmacokinetic (PK), efficacy, and pharmacodynamic data. Total enrollment will depend on the toxicities observed, with approximately 4-24 evaluable subjects enrolled in dose escalation stage.

In group A, participant will receive a single dose and the DLT evaluation period is 14 days.

In group B, Participants will receive administration at D1/D4/D8 of every cycle. The DLT evaluation period will be the first 21-day Cycle in group B. Tumor evaluation was performed every two cycles. The maximum treatment period should not exceed 4 cycles. Group B of cohort X was enrolled only after the DLT assessed for group A of cohort X and SMC approval to proceed to the next cohort assessment.

Dose extension stage: The SMC will evaluate the available safety and preliminary efficacy data and initiate dose-expansion studies for the appropriate indications Phase IIa: To explore the safety of intravenous administration and expand the study in other indications. the stage will be carried out gradually based on the data obtained from the phase I study.

A Study of T3011 Administered Via Intravenously in Patients With Advanced Solid Tumors.

A Phase I/IIa Study to Assess the Safety, Tolerability, Biodistribution and Pharmacodynamic of T3011 Herpes Virus Administered Via Intravenously in Patients With Advanced Solid Tumors.

Measurement of T3011 in subjects' blood, urine, and saliva for biodistribution and viral shedding

Measurement of ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1 (test Nabs when ADAs are positive).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors	NCT05602792	Advanced Solid ... Sarcoma HNSCC Breast Cancer Esophagus Cance... NSCLC Non-melanoma Sk...	T3011 T3011 T3011 T3011 T3011 T3011 T3011	18 Years -	ImmVira Pharma Co. Ltd
HSV G207 Alone or With a Single Radiation Dose in Children With Progressive or Recurrent Supratentorial Brain Tumors	NCT02457845	Supratentorial ... Malignant Gliom... Glioblastoma Anaplastic Astr... PNET Cerebral Primit... Embryonal Tumor	G207	3 Years - 18 Years	University of Alabama at Birmingham
Safety and Effectiveness Study of G207, a Tumor-Killing Virus, in Patients With Recurrent Brain Cancer	NCT00028158	Glioma Astrocytoma Glioblastoma	G207, an oncoly...	19 Years -	MediGene
A Study of T3011 Administered Via Intravenously in Patients With Advanced Solid Tumors.	NCT05598268	Advanced Solid ... Lung Cancer Liver Cancer Lymphoma Mesothelioma of...	T3011	18 Years -	ImmVira Pharma Co. Ltd

Spots Global Cancer Trial Database for herpes virus

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