Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

T3011 will be given intratumorally， Q2W；

T3011

Jun Guo

Mingxi Wang

Xueying Zhang

Yaotiao Deng

Yu Chen

Xianbin Liang

Xiaoshi Zhang

This clinical study evaluated the tolerability, safety and preliminary efficacy of T3011 in subjects with advanced melanoma.

A Clinical Study of T3011 in Subjects With Advanced Melanoma

A Phase Ib/IIa Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of T3011 in Subjects With Advanced Melanoma

Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1

DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease

DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response to the date of disease progression per RECIST v1.1 or death from any cause.

From the start date of study treatment to the date of progression disease or death , whichever occurred first.

Determination of the overall survival time of all patients

Shanghai Pharmaceuticals Holding Co., Ltd

Symptoms and General Pathology

Ascites

T3011 will be administered intraperitoneally twice a week.

Meng Qiu, MD

This is a prospective, open, single-arm, investigator-initiated clinical study to evaluate the safety and efficacy of intraperitoneal administration of T3011 at different doses in the treatment of malignant ascites induced by advanced colorectal cancer.

A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

A Clinical Study of Safety and Efficacy of T3011 Administered Via Intraperitoneal Injection as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer

To evaluate the safety of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites

To evaluate the ORR of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites using B ultrasonography and CT scan

To evaluate the DCR of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites using B ultrasonography and CT scan

To evaluate the effect of intraperitoneal T3011 on the interval of therapeutic abdominal paracentesis in patients with malignant ascites

To evaluate the OS of intraperitoneal T3011 in the treatment of patients with malignant intraperitoneal ascites

The EORTC Core Questionnaire (QLQ-C30) is widely used to measure quality of life in oncology. For self-reported general health and psychological distress, a higher score indicated worse health.

West China Hospital

Prof.

Infections

Digestive System Diseases

Breast Neoplasms

Herpes Simplex

Sarcoma

Virus Diseases

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 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

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Lung Neoplasms

Lymphoma

Liver Neoplasms

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

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 Clinical Study of T3011 in Subjects With Advanced Melanoma	NCT06214156	Advanced Melano...	T3011	18 Years -	Shanghai Pharmaceuticals Holding Co., Ltd
A Clinical Study of Intraperitoneal T3011 Given as a Single Agent in Patients With Malignant Ascites Induced by Advanced Colorectal Cancer	NCT06200376	Malignant Ascit...	T3011	18 Years - 75 Years	West China Hospital
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
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 t3011

Every month we try and update this database with for t3011 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for t3011

Every month we try and update this database with for t3011 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for t3011 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.