^
4d
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
P1/2, N=34, Terminated, Pfizer | Active, not recruiting --> Terminated; Study was terminated due to portfolio re-prioritization and strategic considerations. The decision was not based on any safety concerns and/or regulatory interactions
Trial termination • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
6ms
Trial completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
11ms
SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov)
P1, N=132, Terminated, Seagen Inc. | Trial completion date: Apr 2025 --> Dec 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2025 --> Dec 2023; Study closed due to portfolio prioritization
Trial completion date • Trial termination • Trial primary completion date • Metastases
|
TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
Adcetris (brentuximab vedotin) • sasanlimab (PF-06801591) • SEA-TGT
1year
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
P1/2, N=34, Active, not recruiting, Pfizer | Phase classification: P1b/2 --> P1/2 | Trial primary completion date: Jun 2024 --> May 2023
Phase classification • Trial primary completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1)
|
BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
1year
SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov)
P1, N=132, Active, not recruiting, Seagen Inc. | Recruiting --> Active, not recruiting | N=417 --> 132
Enrollment closed • Enrollment change • Metastases
|
TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
Adcetris (brentuximab vedotin) • sasanlimab (PF-06801591) • SEA-TGT
over1year
Enrollment change • Combination therapy • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • CRP (C-reactive protein)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
almost2years
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
P1b/2, N=24, Active, not recruiting, Pfizer | Trial completion date: Dec 2025 --> Jun 2024 | Trial primary completion date: Jul 2023 --> Jun 2024
Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
almost2years
A preclinical model of acquired anti-PD-1 resistance is responsive to SEA-TGT, an effector-function enhanced anti-TIGIT monoclonal antibody (AACR 2023)
Thus, investigational agents such as SEA-TGT may have the potential to be efficacious in tumors that are primary or secondarily resistant to anti-PD-1 therapy. We have initiated a phase 1 study (NCT04254107) evaluating the safety, tolerability, and activity of SEA-TGT monotherapy and in combination with anti-PD-1 therapy in patients with advanced malignancies.
Preclinical
|
TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
SEA-TGT
almost2years
Using clinical utility index (CUI) to determine the optimal biological dose of a nonfucosylated anti-TIGIT antibody: A proposed alternative to maximum tolerated dose (MTD) (AACR 2023)
Dose selection for SEA-TGT was based on biological activity as assessed via PK/PD endpoints and integrated into a CUI model. Based on the totality of clinical data and the CUI results from monotherapy dose escalation from SGNTGT-001, the SEA-TGT dose of 1 mg/kg was determined to be the lowest biologically active dose with acceptable safety and tolerability.
Clinical
|
CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
SEA-TGT
almost2years
Study of Immunotherapy (Sasanlimab) in Combination With Targeted Therapies in People With Advanced Non-small Cell Lung Cancer (NSCLC) (Landscape 1011 Study) (clinicaltrials.gov)
P1b/2, N=23, Active, not recruiting, Pfizer | Trial completion date: Jun 2027 --> Dec 2025 | Trial primary completion date: Jan 2025 --> Jul 2023
Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
almost2years
Enrollment closed • Enrollment change • Combination therapy • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
2years
SGNTGT-001: A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer (clinicaltrials.gov)
P1, N=397, Recruiting, Seagen Inc. | Trial completion date: Mar 2023 --> Apr 2025 | Trial primary completion date: Dec 2022 --> Jan 2025
Trial completion date • Trial primary completion date • Metastases
|
TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
|
sasanlimab (PF-06801591) • SEA-TGT
2years
Trial completion date • Combination therapy • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
almost3years
Trial primary completion date • Combination therapy • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
3years
Phase 1 study of SEA-TGT, a human, nonfucosylated anti-TIGIT monoclonal antibody with enhanced immune-effector function, in patients with advanced malignancies (SGNTGT-001, trial in progress) (SITC 2021)
Part C will assess SEA-TGT plus sasanlimab in dose-expansion cohorts after an initial safety run-in. This trial is recruiting in Europe and North America. Trial Registration NCT04254107
Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
|
PD-L1 expression
|
sasanlimab (PF-06801591) • SEA-TGT
over3years
Clinical • Trial primary completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
over3years
Clinical • Trial completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • BRAF V600E • BRAF V600
|
Mektovi (binimetinib) • Braftovi (encorafenib) • Inlyta (axitinib) • sasanlimab (PF-06801591) • SEA-TGT
over4years
P1 data • IO biomarker
|
CD8 (cluster of differentiation 8)
|
SEA-TGT