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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
ImmVira Pharma Co. Ltd
Study ID
NCT04370587
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • T3011 — BIOLOGICAL
    T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
  • T3011 + pembrolizumab — COMBINATION_PRODUCT
    T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.

Study Details

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.

Key Dates

Start date
Sep 17, 2020
Status verified
Oct 2025
Primary completion
Sep 22, 2026
Completion
Jan 10, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1
    T3011 single agent dose escalation in participants with solid tumors
  • Experimental: Phase 2a Part 1 Arm A
    RP2D T3011 single agent in participants with melanoma
  • Experimental: Phase 2a Part 1 Arm B
    RP2D T3011 single agent in participants with other solid tumors
  • Experimental: Phase 2a Part 2 Arm C
    RP2D T3011 + pembrolizumab in participants with NSCLC
  • Experimental: Rollover Arm
    RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent

Primary Outcome Measure

Safety and tolerability of escalating doses T3011 [ Time Frame: Up to 2 years from first dose of T3011 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Dana Farber Cancer InstituteBostonMassachusetts02215
Elizabeth Buchbinder, MD
[email protected]
Elizabeth Buchbinder, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Howard Kaufman, MD
[email protected]
Howard Kaufman, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
John Kirkwood, MD
[email protected]
John Kirkwood, MD (PRINCIPAL_INVESTIGATOR)
Mary Crowley Cancer ResearchDallasTexas75230
Minal Barve, MD
[email protected]
Minal Barve, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander Spira, MD
[email protected]

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Banner MD Anderson Cancer Center· Gilbert, AZDana Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MAUniversity of Pittsburgh Medical Center· Pittsburgh, PAMary Crowley Cancer Research· Dallas, TXVirginia Cancer Specialists· Fairfax, VA

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