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igrelimogene litadenorepvec (TILT-123)
i
Other names: TILT-123, Ad5/3-E2F-d24-hTNFa-IRES-hIL2, TNFalpha and IL-2 coding oncolytic adenovirus, PM1016
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Company:
Tilt Biotherap
Drug class:
IL-2 stimulant, TNFα stimulant
Related drugs:
12d
TILT-T776: A Phase I Open-Label, Dose-escalation Clinical Trial of Tumor Necrosis Factor Alpha and Interleukin-2 Coding Oncolytic Adenovirus TILT-123 in combination with avelumab in injectable solid tumor patients (melanoma and SCCHN) refractory to or progressing after anti-PD(L)1 immunotherapy (2024-518088-37-01)
P1, N=9, Completed, TILT Biotherapeutics Oy | Active, not recruiting --> Completed
Trial completion
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Bavencio (avelumab) • igrelimogene litadenorepvec (TILT-123)
21d
TUNIMO: TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 Monotherapy (clinicaltrials.gov)
P1, N=32, Completed, TILT Biotherapeutics Ltd. | Recruiting --> Completed | N=18 --> 32 | Trial completion date: Mar 2025 --> Sep 2025 | Trial primary completion date: Sep 2024 --> Sep 2025
Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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igrelimogene litadenorepvec (TILT-123)
22d
TUNINTIL-2: TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma (clinicaltrials.gov)
P1, N=9, Active, not recruiting, TILT Biotherapeutics Ltd. | Recruiting --> Active, not recruiting
Enrollment closed
|
cyclophosphamide • fludarabine IV • igrelimogene litadenorepvec (TILT-123)
3ms
KEYNOTE-E46: Oncolytic Adenovirus TILT-123 With Pembrolizumab as Treatment for Refractory Non-Small Cell Lung Cancer (clinicaltrials.gov)
P1, N=22, Active, not recruiting, TILT Biotherapeutics Ltd. | Recruiting --> Active, not recruiting
Enrollment closed • Checkpoint inhibition
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Keytruda (pembrolizumab) • igrelimogene litadenorepvec (TILT-123)
5ms
PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. (clinicaltrials.gov)
P1/2, N=29, Recruiting, TILT Biotherapeutics Ltd. | N=76 --> 29
Enrollment change • Platinum resistant
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Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
8ms
AVENTIL: Oncolytic Adenovirus TILT-123 and Avelumab for Treatment of Solid Tumors Refractory to or Progressing After Anti-PD(L)1 (clinicaltrials.gov)
P1, N=15, Active, not recruiting, TILT Biotherapeutics Ltd. | Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2024 --> Dec 2026
Enrollment closed • Trial primary completion date
|
Bavencio (avelumab) • igrelimogene litadenorepvec (TILT-123)
8ms
TUNINTIL: TNFalpha and Interleukin 2 Coding Oncolytic Adenovirus TILT-123 During TIL Treatment of Advanced Melanoma (clinicaltrials.gov)
P1, N=17, Completed, TILT Biotherapeutics Ltd. | Active, not recruiting --> Completed
Trial completion
|
BRAF (B-raf proto-oncogene) • IL2 (Interleukin 2)
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igrelimogene litadenorepvec (TILT-123)
11ms
TUNINTIL-2: TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma (clinicaltrials.gov)
P1, N=9, Recruiting, TILT Biotherapeutics Ltd.
New P1 trial
|
cyclophosphamide • fludarabine IV • igrelimogene litadenorepvec (TILT-123)
11ms
PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab (Phase 1a and 2) and Pegylated Liposomal Doxorubicin (Phase 1b) as Treatment for Ovarian Cancer. (clinicaltrials.gov)
P1/2, N=76, Recruiting, TILT Biotherapeutics Ltd. | Trial completion date: Jun 2026 --> Aug 2027 | Trial primary completion date: Mar 2026 --> Mar 2027 | Phase classification: P1 --> P1/2 | N=29 --> 76
Phase classification • Enrollment change • Trial completion date • Trial primary completion date • Platinum resistant
|
Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
12ms
PROTA: Oncolytic Adenovirus Coding for TNFa and IL2 (TILT-123) With Pembrolizumab or Pembrolizumab and Pegylated Liposomal Doxorubicin as Treatment for Ovarian Cancer. (clinicaltrials.gov)
P1, N=29, Recruiting, TILT Biotherapeutics Ltd. | Trial completion date: Jan 2027 --> Jun 2026 | Trial primary completion date: Jan 2025 --> Mar 2026
Trial completion date • Trial primary completion date • Platinum resistant
|
Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
1year
Safety and efficacy of combined treatment with tumor-infiltrating lymphocytes and oncolytic adenovirus TILT-123 in metastatic melanoma. (PubMed, Cell Rep Med)
In the initial TILT-123 monotherapy phase of the trial, disease control is observed in 6/17 (35%) and 10/16 (63%) in CT and PET, respectively. The study demonstrates good tolerability and preliminary efficacy.
Journal • Tumor-infiltrating lymphocyte
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TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
|
igrelimogene litadenorepvec (TILT-123)
1year
The oncolytic adenovirus TILT-123 with pembrolizumab in platinum resistant or refractory ovarian cancer: the phase 1a PROTA trial. (PubMed, Nat Commun)
Clinical responses were associated with higher serum anti-adenovirus neutralizing antibody titer at baseline and post-treatment. The phase 1b investigating TILT-123, pembrolizumab and PEGylated liposomal doxorubicin in a similar patient population is underway.
P1 data • Journal
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TNFA (Tumor Necrosis Factor-Alpha) • IL2 (Interleukin 2)
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Keytruda (pembrolizumab) • pegylated liposomal doxorubicin • igrelimogene litadenorepvec (TILT-123)
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