NCT05602792

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.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 233 (estimated)
• Sponsor: ImmVira Pharma Co. Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	T3011	T3011 will be administered through intratumoral injection in patients with advanced solid tumors.
BIOLOGICAL	T3011	T3011 will be administered through intratumoral injection in patients with sarcoma.
BIOLOGICAL	T3011	T3011 will be administered through intratumoral injection in patients with Malignant head and neck tumor.
BIOLOGICAL	T3011	T3011 will be administered through intratumoral injection in patients with breast cancer.
BIOLOGICAL	T3011	T3011 will be administered through intratumoral injection in patients with esophagus cancer.
BIOLOGICAL	T3011	T3011 will be administered through intratumoral injection in patients with lung cancer.
BIOLOGICAL	T3011	T3011 will be administered through intratumoral injection in patients with non-melanoma skin cancer.

Timeline

• Start date: 2020-04-21
• Primary completion: 2023-07-01
• Completion: 2024-01-01
• First posted: 2022-11-02
• Last updated: 2022-11-02

Locations

19 sites across 1 country: China