Clinical trial NCT05602792: A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumor
Sarcoma
HNSCC
Breast Cancer
Esophagus Cancer
NSCLC
Non-melanoma Skin Cancer
Keywords: Oncolytic virus
Herpes virus
Lead sponsor: ImmVira Pharma Co. Ltd
Sponsor class: INDUSTRY
First posted: 2022-11-02
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Up to 2 years from first dose of T3011
measure: 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.
timeFrame: Up to 2 years from first dose of T3011
Secondary outcomes:
measure: In part I and part II, Characteristics of biological distribution and biological effect of single dose and multiple dose IT T3011.
timeFrame: Up to 2 years from first dose of T3011
measure: In part I and part II, Evaluation of pharmacodynamics of T3011
timeFrame: Up to 2 years from first dose of T3011
measure: In part I and part II, Evaluation of immunogenicity of T3011
timeFrame: Up to 2 years from first dose of T3011
measure: Overall response rate (ORR)
timeFrame: Up to 2 years from first dose of T3011
measure: Disease control rate (DCR)
timeFrame: Up to 2 years from first dose of T3011
measure: Duration of response (DOR)
timeFrame: Up to 2 years from first dose of T3011
measure: Progression-free survival (PFS)
timeFrame: Up to 2 years from first dose of T3011
measure: In part III,Overall Survival (OS)
timeFrame: Up to 2 years from first dose of T3011
Other outcomes:
measure: In part II and part III,Exploring tumor immunomodulatory mechanism and histological changes after IT T3011
timeFrame: Up to 2 months from first dose of T3011
measure: In part II and part III,Exploring the relationship between genetic changes and drug efficacy
timeFrame: Up to 2 months from first dose of T3011
measure: In part II and part III,Exploring the proliferation and activity of immune cells in blood after IT T3011
timeFrame: Up to 2 years from first dose of T3011
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Guanzhou
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hanzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University Medical College
state: Zhejiang
city: Hanzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
city: Shanghai
country: China
facility: Ninth People's Hospital,Shanghai Jiao Tong University School to Medicine
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
Study officials:
References: