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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
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.
Study details:
This is a Phase 1/2a, open-label, first-in-human study of T3011 given via intratumoral (IT) injection as a single agent and in combination with IV pembrolizumab in participants with advanced or metastatic solid tumors. The Phase 1 portion of the study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of T3011. Total enrollment will depend on the toxicities and/or activity observed, with approximately 15 to 30 evaluable participants enrolled.
Once the RP2D is established Phase 2a Part 1 will enroll approximately 10 participants with locally recurrent or metastatic melanoma (in Arm A) 23 to 53 participants with HNSCC in Arm B, 40 to 80 participants with sarcoma in Arm C and 10 participants with cSCC in Arm D. During Phase 2a Part 1 the safety, tolerability, and preliminary efficacy of T3011 as a single agent will be evaluated. Phase 2a Part 2 will enroll in parallel to Phase 2a Part 1 once the RP2D is established.
The safety, tolerability, and preliminary efficacy of IT T3011 given in combination with IV pembrolizumab will be evaluated in 15 participants with histologically or pathologically confirmed metastatic NSCLC (Arm E). A rollover arm is also included in this study to allow participants who have documented progression on T3011 alone to receive T3011 in combination with pembrolizumab if considered eligible.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2020-09-17
Primary completion: 2023-10-31
Study completion finish: 2025-10-31
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT04370587
Intervention or treatment
BIOLOGICAL: T3011
COMBINATION_PRODUCT: T3011 + pembrolizumab
Conditions
- • Solid Tumor
- • Melanoma
- • NSCLC
- • HNSCC
- • Sarcoma
- • Squamous Cell Carcinoma
Find a site
Closest Location:
Southern Oncology
Research sites nearby
Select from list below to view details:
Southern Oncology
Bedford Park, Not Specified, Australia
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Not Specified, Australia
The Alfred
Melbourne, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Phase 1
| BIOLOGICAL: T3011
|
EXPERIMENTAL: Phase 2a Part 1 Arm A
| BIOLOGICAL: T3011
|
EXPERIMENTAL: Phase 2a Part 1 Arm B
| BIOLOGICAL: T3011
|
EXPERIMENTAL: Phase 2a Part 2 Arm C
| COMBINATION_PRODUCT: T3011 + pembrolizumab
|
EXPERIMENTAL: Rollover Arm
| COMBINATION_PRODUCT: T3011 + pembrolizumab
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Overall response rate (ORR) | ORR is defined as the proportion of participants who have a partial response (PR) or complete response (CR) to intervention, based on assessments by RECIST v1.1 and iRECIST. | Up to 2 years from first dose of T3011 |
Disease control rate (DCR) | DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) based on assessments by RECIST v1.1 and iRECIST. | Up to 2 years from first dose of T3011 |
Duration of response (DOR) | DOR is defined as the time from the first met CR or PR until disease progression or death due to any cause, whichever occurs first. | Up to 2 years from first dose of T3011 |
Durable response (DR) | DR is defined as objective response (CR or PR) according to RECIST v1.1 and iRECIST. | Up to 2 years from first dose of T3011 |
Progression-free survival (PFS) | PFS is defined as the time from enrollment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST v1.1 and iRECIST. | Up to 2 years from first dose of T3011 |
Overall Survival (OS) | OS is defined as the time from enrollment to death from any cause. | Up to 1 year after last dose of T3011 |
Presence of neutralizing antibodies of anti-PD-1 antibody for antidrug antibodies (ADAs) development | To evaluate the immunogenicity of anti-PD-1 antibody expressed by T3011 given as single agent and in combination with pembrolizumab post injection. | Up to 2 years from first dose of T3011 |
Presence and frequency of T3011 in injection site swab, saliva, and urine | To evaluate the virus shedding of T3011 following intratumoral injection | Up to 2 years from first dose of T3011 |
Frequently Asked Questions
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