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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
Sym021
i
Other names: Sym021, Sym 021, S95016, S-95016, Sym-021, S 95016
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News alerts, weekly reports and conference planners
Company:
Servier, Takeda
Drug class:
PD1 inhibitor
Related drugs:
8d
CL1-95029-001: S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jan 2025 --> Jun 2025
Trial completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
|
futuximab/modotuximab (S95026) • S95029 • Sym021
10d
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=48, Completed, Symphogen A/S | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
5ms
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jul 2024 --> Jan 2025
Trial completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
futuximab/modotuximab (S95026) • S95029 • Sym021
6ms
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=78, Completed, Symphogen A/S | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
irinotecan • S95018 • Sym021 • Sym022
8ms
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=78, Active, not recruiting, Symphogen A/S | N=148 --> 78 | Trial completion date: Jan 2025 --> Jun 2024
Enrollment change • Trial completion date • Combination therapy • Metastases
|
FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • FGFR2 mutation • FGFR2 fusion
|
irinotecan • S95018 • Sym021 • Sym022
8ms
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=48, Active, not recruiting, Symphogen A/S | N=100 --> 48
Enrollment change • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
8ms
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=100, Active, not recruiting, Symphogen A/S | Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
8ms
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Feb 2024 --> Jul 2024
Trial completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
|
futuximab/modotuximab (S95026) • S95029 • Sym021
10ms
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=148, Active, not recruiting, Symphogen A/S | Phase classification: P1b --> P1
Phase classification
|
FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • FGFR2 mutation • FGFR2 fusion
|
irinotecan • S95018 • Sym021 • Sym022
10ms
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
P1, N=51, Active, not recruiting, Institut de Recherches Internationales Servier | Recruiting --> Active, not recruiting
Enrollment closed
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
|
futuximab/modotuximab (S95026) • S95029 • Sym021
11ms
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=100, Active, not recruiting, Symphogen A/S | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Jul 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
1year
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
P1, N=41, Recruiting, Institut de Recherches Internationales Servier | Phase classification: P1a/1b --> P1
Phase classification • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
|
futuximab/modotuximab (S95026) • S95029 • Sym021
1year
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=100, Active, not recruiting, Symphogen A/S | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
over1year
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
P1a/1b, N=39, Recruiting, Institut de Recherches Internationales Servier | N=129 --> 39 | Trial completion date: Jul 2025 --> Jan 2024 | Trial primary completion date: May 2023 --> Jan 2024
Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
|
futuximab/modotuximab (S95026) • S95029 • Sym021
over1year
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=100, Recruiting, Symphogen A/S | Trial completion date: Jun 2024 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2023
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
over2years
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
P1b, N=148, Active, not recruiting, Symphogen A/S | Recruiting --> Active, not recruiting
Enrollment closed • Combination therapy
|
FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • FGFR2 mutation • FGFR2 fusion
|
irinotecan • S95018 • Sym021 • Sym022
over2years
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=100, Recruiting, Symphogen A/S | Trial completion date: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
Trial completion date • Trial primary completion date • Combination therapy
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
over2years
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies (clinicaltrials.gov)
P1b, N=148, Recruiting, Symphogen A/S | N=100 --> 148 | Trial primary completion date: Dec 2024 --> Apr 2024
Enrollment change • Trial primary completion date • Combination therapy
|
FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • FGFR2 mutation • FGFR2 fusion
|
irinotecan • S95018 • Sym021 • Sym022
almost3years
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas (clinicaltrials.gov)
P1b, N=100, Recruiting, Symphogen A/S | Active, not recruiting --> Recruiting
Enrollment open • Combination therapy
|
FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • FGFR2 mutation • FGFR2 fusion
|
irinotecan • S95018 • Sym021 • Sym022
3years
S095029 as Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies Followed by an Expansion Part With Triple Combinations in Patients With Metastatic Gastric or Colorectal Cancers (clinicaltrials.gov)
P1a/1b, N=119, Recruiting, Institut de Recherches Internationales Servier
Clinical • New P1 trial • Combination therapy
|
HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
|
BRAF V600E • KRAS wild-type • KRAS exon 2 mutation • KRAS exon 2 wild-type
|
futuximab/modotuximab (S95026) • Sym021
over3years
Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Biliary Tract Carcinomas (clinicaltrials.gov)
P1b, N=100, Active, not recruiting, Symphogen A/S | N=200 --> 100
Clinical • Enrollment change • Combination therapy
|
FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
IDH1 mutation • FGFR2 mutation • FGFR2 fusion
|
irinotecan • S95018 • Sym021 • Sym022
almost4years
[VIRTUAL] Preclinical characterization of Sym024, a novel anti-CD73 antibody (AACR 2021)
In vitro one-way mixed lymphocyte reaction results demonstrate the utility of combining CD73 inhibition with PD-1 blockade, as Sym024 acts to reverse the immune suppressive effect of adenosine production, thereby allowing effective T cell activation by an anti-PD-1 antibody (Sym021). Dose-proportional and linear pharmacokinetics (PK) was observed at high dose levels while nonlinear PK became evident at lower exposure levels. Sym024 is currently under clinical investigation.
Preclinical • PD(L)-1 Biomarker • IO biomarker
|
CD8 (cluster of differentiation 8) • CD73 (5'-Nucleotidase Ecto) • CD4 (CD4 Molecule) • NT5E (5'-Nucleotidase Ecto) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1)
|
CD73 overexpression • CD73 expression • NT5E overexpression
|
S95024 • Sym021
4years
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies (clinicaltrials.gov)
P1, N=100, Recruiting, Symphogen A/S
Clinical • New P1 trial • Combination therapy
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
S95024 • Sym021
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