A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
NCT04370587 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-10-08
Summary
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
Conditions
- Solid Tumor
- Melanoma
- HNSCC
- Sarcoma
- Squamous Cell Carcinoma
- NSCLC
Interventions
- BIOLOGICAL
-
T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
- COMBINATION_PRODUCT
-
T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
Sponsors & Collaborators
-
ImmVira Pharma Co. Ltd
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-17
- Primary Completion
- 2026-09-22
- Completion
- 2027-01-10
- FDA Drug
- Yes
Countries
- United States
- Australia
Study Locations
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