Sym021
/ Servier, Takeda
- LARVOL DELTA
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November 06, 2025
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 | Sponsor: Institut de Recherches Internationales Servier | Trial completion date: Jun 2025 ➔ Mar 2026
Monotherapy • Trial completion date • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
December 11, 2024
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 | Sponsor: Institut de Recherches Internationales Servier | Trial completion date: Jan 2025 ➔ Jun 2025
Combination therapy • Metastases • Monotherapy • Trial completion date • Colorectal Cancer • Gastric Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
December 09, 2024
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
(clinicaltrials.gov)
- P1 | N=48 | Completed | Sponsor: Symphogen A/S | Active, not recruiting ➔ Completed
Combination therapy • Metastases • Monotherapy • Trial completion • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI
October 30, 2024
A phase 1 multicenter study of the safety and efficacy of the NKG2A targeting antibody S095029 as single agent and in combination with anti-PD1 in patients with advanced malignancies
(SITC 2024)
- P1, P1/2 | "Sym021 is an anti-PD1 IgG1 antibody. S095029 is currently investigated in combination with anti-PD1 in patients with previously untreated advanced NSCLC with high PDL1 expression (NCT06162572), and in patients with MSI-H/dMMR advanced gastric/GEJ cancer (NCT06116136). Ethics Approval Written informed consent was provided by all the patients or their legal guardians before participation in the trial, and approval from the institutional review board or independent ethics committee was obtained at each trial site."
Clinical • Combination therapy • IO biomarker • Late-breaking abstract • Metastases • P1 data • Gastric Cancer • Leiomyosarcoma • Lung Cancer • Microsatellite Instability • Non Small Cell Lung Cancer • Oncology • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • CXCL9 • HLA-E • IFNG • KLRC1 • KLRD1 • MSI • PD-L1 • TNFA
August 02, 2024
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 | Sponsor: Institut de Recherches Internationales Servier | Trial completion date: Jul 2024 ➔ Jan 2025
Combination therapy • Metastases • Monotherapy • Trial completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
June 26, 2024
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 | Sponsor: Symphogen A/S | Active, not recruiting ➔ Completed
Combination therapy • Metastases • Trial completion • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1
April 24, 2024
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 | Sponsor: Symphogen A/S | N=148 ➔ 78 | Trial completion date: Jan 2025 ➔ Jun 2024
Combination therapy • Enrollment change • Metastases • Trial completion date • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1
April 24, 2024
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
(clinicaltrials.gov)
- P1 | N=48 | Active, not recruiting | Sponsor: Symphogen A/S | N=100 ➔ 48
Combination therapy • Enrollment change • Metastases • Monotherapy • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI
April 19, 2024
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
(clinicaltrials.gov)
- P1 | N=100 | Active, not recruiting | Sponsor: Symphogen A/S | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: Jul 2024 ➔ Dec 2024
Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI
March 06, 2024
A phase 1b multicenter study of anti-TIM3 (S095018/Sym023) in combination with anti-PD1 (Sym021) in patients with advanced/metastatic recurrent biliary tract cancer
(AACR 2024)
- P1 | "S095018 in combination with Sym021 exhibited antitumor activity in patients with advanced/metastatic recurrent biliary tract cancer who had not received prior treatment with PD-1/-L1 inhibitors. The combination was well tolerated without new safety signals. Further biomarker analysis is ongoing."
Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CD8 • IFNG • PD-L2
March 06, 2024
Molecular and early clinical characterization of the anti-CD73 antibody S095024 (Sym024)
(AACR 2024)
- P1 | "The clinical safety, tolerability, pharmacokinetics, and pharmacodynamics of S095024 alone or in combination with Sym021, an anti-PD1 antibody, was investigated in a first-in-human study (NCT04672434) in patients with selected types of advanced solid tumors. These findings reveal the potential of S095024 (Sym024) to prevent adenosine-mediated tumor evasion and support further clinical investigation."
Clinical • IO biomarker • Oncology • Solid Tumor • CD73 • ENTPD1 • NT5E
April 09, 2024
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 | Sponsor: Institut de Recherches Internationales Servier | Trial completion date: Feb 2024 ➔ Jul 2024
Combination therapy • Metastases • Monotherapy • Trial completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
February 28, 2024
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 | Sponsor: Symphogen A/S | Phase classification: P1b ➔ P1
Phase classification • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1
February 13, 2024
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 | Sponsor: Institut de Recherches Internationales Servier | Recruiting ➔ Active, not recruiting
Enrollment closed • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
January 17, 2024
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
(clinicaltrials.gov)
- P1 | N=100 | Active, not recruiting | Sponsor: Symphogen A/S | Trial completion date: Dec 2023 ➔ Jul 2024 | Trial primary completion date: Dec 2023 ➔ Jul 2024
Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI
December 06, 2023
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 | Sponsor: Institut de Recherches Internationales Servier | Phase classification: P1a/1b ➔ P1
Combination therapy • Metastases • Monotherapy • Phase classification • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
October 04, 2023
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
(clinicaltrials.gov)
- P1 | N=100 | Active, not recruiting | Sponsor: Symphogen A/S | Recruiting ➔ Active, not recruiting
Combination therapy • Enrollment closed • Metastases • Monotherapy • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI
July 28, 2023
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 | Sponsor: Institut de Recherches Internationales Servier | N=129 ➔ 39 | Trial completion date: Jul 2025 ➔ Jan 2024 | Trial primary completion date: May 2023 ➔ Jan 2024
Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
May 31, 2023
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
(clinicaltrials.gov)
- P1 | N=100 | Recruiting | Sponsor: Symphogen A/S | Trial completion date: Jun 2024 ➔ Dec 2023 | Trial primary completion date: Jun 2024 ➔ Dec 2023
Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI
September 11, 2019
A phase I study of Sym021, an anti-PD-1 antibody (Ab), alone and in combination with Sym022 (anti-LAG-3) or Sym023 (anti-TIM-3)
(ESMO 2019)
- P1; "Sym021 alone was well tolerated and demonstrated both immune modulation and antitumor activity. Evaluation of single agent dose-escalation trials of Sym022 and Sym023 and of the Sym021/Sym022 and Sym021/Sym023 combination arms are ongoing. Results from these studies will be presented."
Combination therapy • P1 data • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Lymphoma • Oncology
July 21, 2020
[VIRTUAL] Phase I studies of Sym021, an anti-PD-1 antibody, alone and in combination with Sym022 (anti-LAG-3) or Sym023 (anti-TIM-3)
(ESMO 2020)
- P1 | "Funding: Symphogen. Clinical trial identification: NCT03311412; NCT03489369; NCT03489343."
Combination therapy • IO biomarker • P1 data • Hematological Malignancies • Oncology • Solid Tumor
September 09, 2022
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 | Sponsor: Symphogen A/S | Recruiting ➔ Active, not recruiting
Combination therapy • Enrollment closed • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1
July 12, 2022
Sym024 Monotherapy and in Combination With Sym021 in Patients With Advanced Solid Tumor Malignancies
(clinicaltrials.gov)
- P1 | N=100 | Recruiting | Sponsor: Symphogen A/S | Trial completion date: Mar 2024 ➔ Jun 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024
Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • MSI
May 18, 2022
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 | Sponsor: Symphogen A/S | N=100 ➔ 148 | Trial primary completion date: Dec 2024 ➔ Apr 2024
Combination therapy • Enrollment change • Trial primary completion date • Biliary Tract Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • FGFR2 • IDH1
December 17, 2021
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; Sponsor: Institut de Recherches Internationales Servier
Clinical • Combination therapy • Monotherapy • New P1 trial • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS
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