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

Phase 1

Recruiting

• Conditions: Breast Cancer; Advanced Solid Tumor; Sarcoma; NSCLC; Non-melanoma Skin Cancer; HNSCC; Esophagus Cancer
• Interventions: Biological: T3011

• Registration Number: NCT05602792
• Lead Sponsor: ImmVira Pharma Co. Ltd

Brief Summary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-21
• Status Verified: 2022-10
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-30
• Last Update Submitted: 2022-10-30
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-07
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 233

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.

  2. 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.

  3. 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.

  4. WCBP must have a negative serum pregnancy test Within 7 days prior to W1D1. 9. Capable of understanding and complying with protocol requirements.

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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.

  2. 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.

  3. Requires continued concurrent therapy with any drug active against HSV. 7. Pregnant or lactating.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
T3011 Herpes Virus Injection	T3011	-

Primary Outcome Measures

Name	Time	Method
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.	Up to 2 years from first dose of T3011	Incidence rate of TEAE;
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.	Up to 2 years from first dose of T3011	Incidence rate of TEAE; Incidence rate of DLT

Secondary Outcome Measures

Name	Time	Method
In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.	Up to 2 years from first dose of T3011	The changes of PD-1 and IL-12 concentration after administration
In part I and part II, Evaluation of immunogenicity of T3011	Up to 2 years from first dose of T3011	ADAs and Nabs of IL-12, anti-PD-1 antibody and HSV-1
Duration of response (DOR)	Up to 2 years from first dose of T3011	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.
In part I and part II, Evaluation of pharmacodynamics of T3011	Up to 2 years from first dose of T3011	IFN-γ、 IL-1β、 IL-2、 IL-4、 IL-6、 IL-8、 IL-10、 IL-13、 TNF-α
Overall response rate (ORR)	Up to 2 years from first dose of T3011	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.
In part III,Overall Survival (OS)	Up to 2 years from first dose of T3011	OS is defined as the time from enrollment to death from any cause.
Disease control rate (DCR)	Up to 2 years from first dose of T3011	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.
Progression-free survival (PFS)	Up to 2 years from first dose of T3011	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.

Trial Locations

Locations (19)

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Anhui Provincial Hospital; 🇨🇳 Hefei, Anhui, China

The Fifth Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guanzhou, Guangdong, China

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China

Liaoning Cancer Hospital; 🇨🇳 Shenyang, Liaoning, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Jiangxi Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital of Zhejiang University Medical College; 🇨🇳 Hanzhou, Zhejiang, China

Peking University First Hospital; 🇨🇳 Beijing, China

Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine; 🇨🇳 Shanghai, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, China

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hanzhou, Zhejiang, China

Zhongshan Hospital; 🇨🇳 Shanghai, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, China

The Second People's Hospital of Shenzhen; 🇨🇳 Shenzhen, China