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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602792
• Other study ID #: TG1819ONC
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 21, 2020
• Est. completion date: January 2024

Study information

• Verified date: October 2022
• Source: ImmVira Pharma Co. Ltd
• Contact: ImmVira Pharma Co. LTD
• Phone: 781-718-5121
• Email: clinicaltrials[@]immviragroup.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 233
• Est. completion date: January 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Breast Cancer
• Esophageal Neoplasms
• Esophagus Cancer
• HNSCC
• Non-melanoma Skin Cancer
• NSCLC
• Sarcoma

Intervention

Biological:
• T3011
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
T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.
• T3011
T3011 will be administered through intratumoral injection in patients with breast cancer.
• T3011
T3011 will be administered through intratumoral injection in patients with esophagus cancer.
• T3011
T3011 will be administered through intratumoral injection in patients with lung cancer.
• T3011
T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.

Locations

Country	Name	City	State
China	Beijing Jishuitan Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The Fifth Affiliated Hospital of Sun Yat-sen University	Guanzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang University Medical College	Hanzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hanzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi
China	Fudan University Cancer Hospital	Shanghai
China	Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai
China	Zhongshan Hospital	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The Second People's Hospital of Shenzhen	Shenzhen
China	Wuhan Union Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
ImmVira Pharma Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	In part II and part III,Exploring tumor immunomodulatory mechanism and histological changes after IT T3011	Assesse histological changes by immunohistochemical fluorescence detection	Up to 2 months from first dose of T3011
Other	In part II and part III,Exploring the relationship between genetic changes and drug efficacy	Genetic testing of tumor tissue	Up to 2 months from first dose of T3011
Other	In part II and part III,Exploring the proliferation and activity of immune cells in blood after IT T3011	Analysis of immune cells in blood	Up to 2 years from first dose of T3011
Primary	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	Up to 2 years from first dose of T3011
Primary	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;	Up to 2 years from first dose of T3011
Secondary	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	Up to 2 years from first dose of T3011
Secondary	In part I and part II, Evaluation of pharmacodynamics of T3011	IFN-?? IL-1ß? IL-2? IL-4? IL-6? IL-8? IL-10? IL-13? TNF-a	Up to 2 years from first dose of T3011
Secondary	In part I and part II, Evaluation of immunogenicity of T3011	ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1	Up to 2 years from first dose of T3011
Secondary	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.	Up to 2 years from first dose of T3011
Secondary	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.	Up to 2 years from first dose of T3011
Secondary	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.	Up to 2 years from first dose of T3011
Secondary	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.	Up to 2 years from first dose of T3011
Secondary	In part III,Overall Survival (OS)	OS is defined as the time from enrollment to death from any cause.	Up to 2 years from first dose of T3011