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DRUG:

T3011

i
Other names: T3011, MVR-T3011, B015
Associations
Company:
ImmVira Pharma, Shanghai Pharma
Drug class:
PD1 inhibitor, IL-12 stimulant
Related drugs:
Associations
2ms
Intravenous T3011 Given as a Single Agent and in Combination With Other Therapy in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=42, Active, not recruiting, ImmVira Pharma Co. Ltd | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
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T3011
2ms
New P1 trial
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Loqtorzi (toripalimab-tpzi) • Stivarga (regorafenib) • T3011
3ms
T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma (clinicaltrials.gov)
P2, N=68, Suspended, ImmVira Pharma Co. Ltd | Phase classification: P2a --> P2 | Trial completion date: Jan 2026 --> Jan 2027 | Not yet recruiting --> Suspended | Trial primary completion date: Dec 2025 --> Dec 2026
Phase classification • Trial completion date • Trial suspension • Trial primary completion date • Combination therapy • Metastases
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BRAF (B-raf proto-oncogene)
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BRAF V600E • BRAF V600 • BRAF V600K • RAS mutation • BRAF V600E + BRAF V600K
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Cotellic (cobimetinib) • T3011
3ms
A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov)
P1/2, N=42, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting --> Recruiting
Enrollment open
|
T3011
3ms
A Clinical Study of T3011 in Combination With PD-1/PD-L1 Inhibitors in Subjects With Advanced Solid Tumors (clinicaltrials.gov)
P1/2, N=68, Recruiting, Shanghai Pharmaceuticals Holding Co., Ltd | Not yet recruiting --> Recruiting
Enrollment open • Combination therapy • Metastases
|
T3011
4ms
A Clinical Study of T3011 in Subjects With Advanced Melanoma (clinicaltrials.gov)
P1/2, N=42, Not yet recruiting, Shanghai Pharmaceuticals Holding Co., Ltd
New P1/2 trial • Metastases
|
T3011
4ms
New P1/2 trial • Combination therapy • Metastases
|
T3011
4ms
New P1 trial • Combination therapy • Metastases
|
Stivarga (regorafenib) • T3011
8ms
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 (clinicaltrials.gov)
P1/2, N=64, Recruiting, ImmVira Pharma Co. Ltd | Trial completion date: Aug 2030 --> Oct 2025 | Trial primary completion date: Jul 2030 --> Oct 2023
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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ALK rearrangement
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Keytruda (pembrolizumab) • T3011
11ms
T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma (clinicaltrials.gov)
P2a, N=68, Not yet recruiting, ImmVira Pharma Co. Ltd | Initiation date: Mar 2023 --> Jun 2023
Trial initiation date • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • BRAF V600K • RAS mutation • BRAF V600E + BRAF V600K
|
Cotellic (cobimetinib) • T3011
1year
Intravenous (IV) infusion of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, as monotherapy in advanced solid tumors: Preliminary results from an ongoing phase 1/2a study. (ASCO 2023)
IV T3011 monotherapy was well tolerated and safe at the first 3 dose levels, highly unlikely to be transmissible. Preliminary efficacy was encouraging. Our results also suggest T3011 IV treatment could stimulate anti-tumor immunity in the tumor microenvironment.
P1/2 data • Metastases
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T3011
1year
Updated results from an ongoing phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via IT injection as monotherapy or combined with pembrolizumab in advanced solid tumors. (ASCO 2023)
Both T3011 IT monotherapy and combination therapy with pembrolizumab were safe and tolerable. The efficacy of T3011 in immune-resistant melanoma was encouraging. Our data suggest T3011 may modify the tumor microenvironment and overcome immune resistance.
P1/2 data • Metastases
|
CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
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Keytruda (pembrolizumab) • T3011
1year
A phase 1/2a study of T3011, an oncolytic HSV expressing IL-12 and PD-1 antibody, administered via intratumoral (IT) injection as monotherapy in advanced solid tumors. (ASCO 2023)
The safety profile and clinical compliance of T3011 IT therapy are excellent. T3011 injected locally will not spread to blood, urine and saliva, regional shedding doesn't raise the possibility of transmission to the local and systemic environment. The encouraging anti-tumor activity of T3011 monotherapy in advanced HNSCC pts supports further evaluation in phase II studies.
P1/2 data • Metastases
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T3011
1year
“Armed” oncolytic herpes simplex virus enables CD19 CAR-T for solid tumor cell treatment as a combination therapy (AACR 2023)
The in vivo efficacy studies demonstrated that IT and IP administration of T7011, rather than MVR-T3011 virus which lacks CD19, specifically promoted CD19 CAR-T anti-solid tumor activities in both immunodeficient and immunocompetent mice. The new-generation of HSV oncolytic virus T7011 expressing the targetable CD19 antigen on tumor surface enables the CD19 CAR-T for solid tumor cell treatment as a combination therapy. The new-generation of HSV oncolytic virus T7011 expressing the targetable CD19 antigen on tumor surface enables the CD19 CAR-T for solid tumor cell treatment as a combination therapy. In addition, T7011 also carries multi-immunomodulators further to enhance antitumor efficacy by reinvigorating the infiltrated CAR-T cells and reversing the immunosuppressive TME. T7011 is expected to be a promising combinational therapy with CD19-specific CAR-T cells enabling effective cell therapy against multiple solid tumors.
Combination therapy • PD(L)-1 Biomarker • IO biomarker • Tumor cell
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CD19 (CD19 Molecule)
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CD19 expression
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MVR-T7011 • T3011
1year
New P2a trial • Combination therapy • Metastases
|
BRAF (B-raf proto-oncogene)
|
BRAF V600E • BRAF V600 • BRAF V600K • RAS mutation
|
Cotellic (cobimetinib) • T3011
over1year
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 (clinicaltrials.gov)
P1/2, N=64, Recruiting, ImmVira Pharma Co. Ltd | Trial completion date: Oct 2024 --> Aug 2030 | Trial primary completion date: Oct 2022 --> Jul 2030
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
|
ALK rearrangement
|
Keytruda (pembrolizumab) • T3011