Drugs / Spartalizumab
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Spartalizumab

Monoclonal antibody targets PDCD1 via inhibition

Developed for
non-small cell lung carcinoma · colorectal cancer · melanoma · triple-negative breast carcinoma · cancer · hepatocellular carcinoma · esophageal squamous cell carcinoma · head and neck squamous cell carcinoma
+58 more · clear cell renal carcinoma · esophageal adenocarcinoma · gastric adenocarcinoma · malignant pancreatic neoplasm · pancreatic adenocarcinoma · chronic myelomonocytic leukemia · diffuse large B-cell lymphoma · gastrointestinal stromal tumor · lung cancer · malignant epithelial tumor of ovary · myelodysplastic syndrome · nasopharyngeal carcinoma · pancreatic ductal adenocarcinoma · prostate adenocarcinoma · renal cell carcinoma · small cell lung carcinoma · soft tissue sarcoma · squamous cell lung carcinoma · urothelial carcinoma · acute myeloid leukemia · anal carcinoma · breast cancer · cancer of unknown primary site · cervical carcinoma · cholangiocarcinoma · colorectal adenocarcinoma · cutaneous melanoma · endometrial carcinoma · gastric cancer · glioblastoma · head and neck cancer · HER2 positive breast carcinoma · hormone receptor-positive breast cancer · kidney cancer · lung adenocarcinoma · lymphoma · mesothelioma · metastatic malignant neoplasm · myelofibrosis · neuroendocrine carcinoma · non-functional pancreatic neuroendocrine tumor · ovarian adenocarcinoma · ovarian carcinoma · Parkinson disease · plasma cell myeloma · poorly differentiated thyroid gland carcinoma · premalignant hematological system disease · primary myelofibrosis · prostate cancer · refractory malignant neoplasm · sarcoma · thymic neuroendocrine tumor · thyroid gland carcinoma · thyroid gland follicular carcinoma · thyroid gland papillary carcinoma · thyroid gland undifferentiated (anaplastic) carcinoma · uterine carcinosarcoma · uveal melanoma
Investigated by
Novartis Pharmaceuticals · Novartis · Asan Medical Center · Pancreatic Cancer Action Network · Yonsei University · Assistance Publique - Hôpitaux de Paris
+21 more · Columbia University · Dana-Farber Cancer Institute · EUSA Pharma, Inc. · Emory University · Fondation ARC · H. Lee Moffitt Cancer Center and Research Institute · M.D. Anderson Cancer Center · Massachusetts General Hospital · Memorial Sloan Kettering Cancer Center · Muhammad Furqan · National Cancer Institute (NCI) · National Cancer Institute, France · National Institutes of Health (NIH) · National Taiwan University Hospital · Palobiofarma SL · Ruijin Hospital · SOLTI Breast Cancer Research Group · Seoul National University Hospital · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Stand Up To Cancer · University Hospital, Bordeaux

Trials 64 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT04237649 Feb 2020 → Sep 2023 cancer Novartis Pharmaceuticals Terminated No outcome recorded
Phase 0 NCT04028245 Aug 2019 → Mar 2025 clear cell renal carcinoma Columbia University Completed No outcome recorded
Phase 131 trials
Phase 1 NCT07157345 Oct 2025 → Jan 2029 expected Parkinson disease Ruijin Hospital Recruiting No outcome recorded
Phase 1 NCT04895748 Nov 2021 → Feb 2026 clear cell renal carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT04283526 Nov 2020 → Apr 2024 myelofibrosis, primary myelofibrosis Novartis Pharmaceuticals Withdrawn No outcome recorded
Phase 1 NCT04581343 Nov 2020 → Nov 2022 pancreatic ductal adenocarcinoma Pancreatic Cancer Action Network Completed No outcome recorded
Phase 1 NCT04294160 Jul 2020 → Sep 2024 colorectal cancer Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT04213404 Mar 2020 → Jan 2024 head and neck squamous cell carcinoma National Taiwan University Hospital Unknown No outcome recorded
Phase 1 NCT04261439 Feb 2020 → Dec 2023 melanoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1 NCT03961971 Feb 2020 → Nov 2022 overdue glioblastoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Active not recruiting No outcome recorded
Phase 1 NCT04058756 Oct 2019 → Apr 2030 expected cancer Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 1 NCT03982134 Sep 2019 → May 2021 melanoma, non-small cell lung carcinoma Muhammad Furqan Withdrawn No outcome recorded
Phase 1/210 trials
Phase 1/2 NCT05210413 May 2022 → Aug 2025 overdue refractory malignant neoplasm University Hospital, Bordeaux Active not recruiting No outcome recorded
Phase 1/2 NCT04191421 Jan 2020 → Apr 2023 pancreatic adenocarcinoma Emory University Completed No outcome recorded
Phase 1/2 NCT03609424 Feb 2019 → Nov 2021 gastrointestinal stromal tumor Asan Medical Center Completed No outcome recorded
Phase 1/2 NCT02829723 Oct 2016 → Dec 2022 cancer Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT02807844 Jun 2016 → Jun 2020 endometrial carcinoma, melanoma, triple-negative breast carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT02795429 Jun 2016 → Jun 2021 hepatocellular carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT02608268 Nov 2015 → Aug 2022 cancer Novartis Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT02460224 Jun 2015 → Dec 2020 cancer Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT02404441 Apr 2015 → Jul 2020 melanoma, non-small cell lung carcinoma, thyroid gland undifferentiated (anaplastic) carcinoma, triple-negative breast carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 1/2 NCT02325739 Dec 2014 → May 2019 hepatocellular carcinoma Novartis Pharmaceuticals Completed No outcome recorded
Phase 219 trials
Phase 2 NCT05201066 Feb 2023 → Feb 2028 expected chronic myelomonocytic leukemia, myelodysplastic syndrome Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 2 NCT05135845 Mar 2022 → Apr 2023 esophageal adenocarcinoma, gastric adenocarcinoma Assistance Publique - Hôpitaux de Paris Suspended No outcome recorded
Phase 2 NCT04802876 Apr 2021 → Sep 2025 overdue HER2 positive breast carcinoma, anal carcinoma, cancer of unknown primary site, cervical carcinoma +21 SOLTI Breast Cancer Research Group Active not recruiting No outcome recorded
Phase 2 NCT04390763 Oct 2020 → Apr 2024 pancreatic ductal adenocarcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT04544111 Sep 2020 → Sep 2026 expected poorly differentiated thyroid gland carcinoma, thyroid gland follicular carcinoma, thyroid gland papillary carcinoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04323436 Aug 2020 → Dec 2022 non-small cell lung carcinoma Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT03785496 Feb 2020 → Jan 2022 esophageal squamous cell carcinoma Yonsei University Unknown No outcome recorded
Phase 2 NCT04310397 Jan 2020 → Oct 2023 cutaneous melanoma M.D. Anderson Cancer Center Terminated No outcome recorded
Phase 2 NCT03945227 Jun 2019 → Jan 2022 non-small cell lung carcinoma Yonsei University Withdrawn No outcome recorded
Phase 2 NCT03694977 Jan → Dec 2019 gastric cancer Seoul National University Hospital Unknown No outcome recorded
Phase 32 trials
Phase 3 NCT04229004 Jan 2020 → Feb 2025 pancreatic adenocarcinoma Pancreatic Cancer Action Network Completed No outcome recorded
Phase 3 NCT02967692 Feb 2017 → Aug 2020 melanoma Novartis Pharmaceuticals Terminated No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT03172936 Background Sep 2017 → Dec 2020 lymphoma Novartis Pharmaceuticals Terminated No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2020-09-19 Novartis Pharmaceuticals Novartis reports late-breaking data from Phase III COMBI-i trial of spartalizumab (PDR001) with Tafinlar® and Mekinist® in advanced melanoma novartis.com
2020-08-22 Novartis Pharmaceuticals Novartis provides update on Phase III study evaluating investigational spartalizumab (PDR001) in combination with Tafinlar® + Mekinist® in advanced melanoma novartis.com

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 71 sources stand behind the page.

FieldValueCited text
Known as spartalizumab “This study was a first in human (FIH), open-label, Phase I-Ib/II, multi-center study which consisted of a Phase I dose escalation part of sabatolimab (MBG453) as single agent,...” NCT02608268
28

spartalizumab (PDR001), a high-affinity, ligand-blocking, humanized anti-PD-1 immunoglobulin G4 antibody, with lacnotuzumab (MCS110), a high-affinity, humanized monoclonal...” PMID 38721402 May 2024

“Phase I Study of Taminadenant (PBF509/NIR178), an Adenosine 2A Receptor Antagonist, with or without Spartalizumab (PDR001), in Patients with Advanced Non-Small Cell Lung Cancer.” PMID 35254415 Jun 2022

“A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors.” PMID 32179633 Mar 2020

“Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) ± anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies.” PMID 35217575 Feb 2022

“Monoclonal antibodies, such as MBG453 and spartalizumab may interfere with the ability of tumor cells to grow and spread.” NCT03961971

Spartalizumab (PDR001) is a humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).” PMID 38919826 Jun 2024

NCT05201066

NCT02967692

NCT04191421

NCT04261439

NCT04229004

NCT03647488

NCT04028245

NCT02605967

NCT04213404

NCT03081494

NCT04581343

NCT05210413

NCT04323436

NCT04000529

NCT04802876

NCT03742349

NCT04390763

NCT02795429

NCT04283526

NCT05135845

NCT04310397

NCT04294160

Known as ANTI-PD1 MONOCLONAL ANTIBODY PDR001 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297831
Known as Espartalizumab ChEMBL registry synonym — accepted as the source's own label CHEMBL4297831
Known as NVP-LZV184 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297831
Known as PDR001 PDR001 (also referred to as spartalizumab) is a humanized monoclonal antibody (mAb) directed against human programmed death-1 (PD-1) that blocks the interaction between PD-1...” NCT05210413
44

“This study combines canakinumab (ACZ885), a high-affinity human anti-interleukin-1β (IL-1β) monoclonal antibody (mAb), and spartalizumab (PDR001), a mAb directed against human...” NCT04581343

“Phase I Study of Taminadenant (PBF509/NIR178), an Adenosine 2A Receptor Antagonist, with or without Spartalizumab (PDR001), in Patients with Advanced Non-Small Cell Lung Cancer.” PMID 35254415 Jun 2022

“Our prior work identified tat-βsyn-deg (PDR-001), a three-segment peptide that selectively targets α-synuclein.” NCT07157345

NCT02936102

NCT01351103

NCT02988440

NCT03693326

NCT03207867

NCT03064854

NCT02740270

NCT02829723

NCT03945227

NCT03365791

NCT02947165

NCT02608268

NCT02955069

NCT03484923

NCT03301896

NCT02460224

NCT07157345

NCT03891953

NCT03294694

NCT03694977

NCT03172936

NCT03176264

NCT03785496

NCT04895748

NCT04544111

NCT02607813

NCT02900664

NCT02325739

NCT02807844

NCT03499899

NCT03982134

NCT04058756

NCT03609424

NCT03066648

NCT02890069

NCT03111992

NCT02404441

NCT02678260

NCT02452268

NCT04237649

NCT03668431

Known as sparatlizumab “We performed a proof-of-concept single-arm phase 2 clinical trial of combined PD-1, BRAF and MEK inhibition with sparatlizumab (PDR001), dabrafenib and trametinib in 37...” PMID 36702949 Jan 2023
Known as Spartalizumab/PDR001 Spartalizumab/PDR001NCT02900664
Known as tat-βsyn-deg “Our prior work identified tat-βsyn-deg (PDR-001), a three-segment peptide that selectively targets α-synuclein.” NCT07157345
Action Inhibit “PDR001 is a humanized anti-PD1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2” NCT02325739
Modality Monoclonal antibody “PDR001 is a humanized anti-PD1 IgG4 antibody” NCT02325739
Route Intravenous Intravenous PDR001 was administered in a fixed dosing regimen of 300 mg iv every three weeks” NCT02325739
Target PDCD1 “anti-PD-1 spartalizumab (PDR001)” PMID 35217575 Feb 2022