NCT04370587

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
8mo left

Started Sep 2020

Longer than P75 for phase_1

Geographic Reach
2 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Sep 2020Jan 2027

First Submitted

Initial submission to the registry

April 14, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2027

Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

6 years

First QC Date

April 14, 2020

Last Update Submit

October 6, 2025

Conditions

Solid TumorMelanomaHNSCCSarcomaSquamous Cell CarcinomaNSCLC

Outcome Measures

Primary Outcomes (5)

  • Safety and tolerability of escalating doses T3011

    Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

    Up to 2 years from first dose of T3011

  • To determine the dose(s) of T3011 to be examined in Phase 2a

    Incidence of DLTs

    Through the first two T3011 injections (approximately 28 days)

  • Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts

    Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

    Up to 2 years from first dose of T3011

  • Characterize the safety and tolerability of T3011 in combination with pembrolizumab

    Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

    Up to 2 years from first dose of T3011

  • Characterize the safety and tolerability of T3011 in combination with pembrolizumab in participants who progress on T3011 alone

    Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.

    Up to 2 years from first dose of T3011

Secondary Outcomes (8)

  • Overall response rate (ORR)

    Up to 2 years from first dose of T3011

  • Disease control rate (DCR)

    Up to 2 years from first dose of T3011

  • Duration of response (DOR)

    Up to 2 years from first dose of T3011

  • Durable response (DR)

    Up to 2 years from first dose of T3011

  • Progression-free survival (PFS)

    Up to 2 years from first dose of T3011

  • +3 more secondary outcomes

Study Arms (5)

Phase 1

EXPERIMENTAL

T3011 single agent dose escalation in participants with solid tumors

Biological: T3011

Phase 2a Part 1 Arm A

EXPERIMENTAL

RP2D T3011 single agent in participants with melanoma

Biological: T3011

Phase 2a Part 1 Arm B

EXPERIMENTAL

RP2D T3011 single agent in participants with other solid tumors

Biological: T3011

Phase 2a Part 2 Arm C

EXPERIMENTAL

RP2D T3011 + pembrolizumab in participants with NSCLC

Combination Product: T3011 + pembrolizumab

Rollover Arm

EXPERIMENTAL

RP2D T3011 + pembrolizumab in participants who have progressed on T3011 single agent

Combination Product: T3011 + pembrolizumab

Interventions

T3011BIOLOGICAL

T3011 will be administered up to 4mL as an intratumoral injection given Q2W.

Phase 1Phase 2a Part 1 Arm APhase 2a Part 1 Arm B
T3011 + pembrolizumabCOMBINATION_PRODUCT

T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.

Phase 2a Part 2 Arm CRollover Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older.
  • Disease progression after standard of care (SOC) therapy or in the opinion of
  • Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
  • ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1/PDL1 blockade after receiving at least 2 doses alone or in combination.
  • iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies.
  • iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic disease.
  • Phase 2a Part 2 i.v. Arm E - Histologically or pathologically confirmed NSCLC that is advanced or recurrent, without EGFR mutation or ALK rearrangement. Participants must have received at least one line but no more than three lines of prior anti-cancer therapies.
  • Measurable disease per RECIST version 1.1.
  • Must have at least 1 tumor lesion that is accessible for IT injection of T3011 in the opinion of the investigator.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Life expectancy \> 12 weeks.
  • Demonstrate adequate organ function as defined by acceptable laboratory testing results.
  • 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. WCBP must have a negative serum pregnancy test prior to W1D1.
  • Last dose of previous anticancer therapy ≥ 21 days, radiotherapy \> 21 days, or surgical intervention \> 21 days prior to the first dose of T3011.
  • Recovered from all prior anticancer therapy toxicities.
  • +3 more criteria

You may not qualify if:

  • Have only uninjectable tumors..
  • Patients with injectable tumors impinging upon major airways or blood vessels.
  • HNSCC only: Prior re-irradiation field containing carotid artery.
  • Greater than 3 distant metastatic lymph node regions and/or metastatic lesions or the largest distant metastases with a diameter of more than 3 cm (non-sarcoma)/5 cm (sarcoma) unless the lesion is to be injected.
  • Prior treatment with another OV (including T-VEC), tumor vaccines, cellular therapy or gene therapy.
  • Prior intolerance to anti-PD-(L)1 monoclonal antibody or history of immunotherapy related non-infectious pneumonitis/interstitial lung disease.
  • Prior treatment with anti-PD-(L)1 monoclonal antibody in combination with IL-12.
  • Requires continued concurrent therapy with any drug active against HSV.
  • Live vaccines, attenuated vaccines within 4 weeks prior to initiation of study treatment (participants vaccinated with inactivated vaccines can be enrolled.
  • Primary or acquired immunodeficient states.
  • Pregnant or lactating.
  • Prior organ transplantation.
  • Active hepatitis B virus, hepatitis C virus, and HIV infection or a positive serological test at Screening within 14 days of dosing with T3011.
  • Active autoimmune disease or medical conditions requiring chronic steroid or immunosuppressive therapy within 4 weeks prior to first administration of study treatment.
  • History of or current central nervous system metastases.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

COMPLETED

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Southern Oncology

Bedford Park, Australia

RECRUITING

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Australia

RECRUITING

The Alfred

Melbourne, Australia

RECRUITING

MeSH Terms

Conditions

MelanomaSquamous Cell Carcinoma of Head and NeckSarcomaCarcinoma, Squamous Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialHead and Neck NeoplasmsNeoplasms, Connective and Soft TissueNeoplasms, Squamous Cell

Central Study Contacts

ImmVira Pharma Co. Ltd.

CONTACT

781-718-5121clinicaltrials@immviragroup.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

May 1, 2020

Study Start

September 17, 2020

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

January 10, 2027

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(6)AU(3)