Drugs / Monalizumab
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Monalizumab

Monoclonal antibody targets KLRC1

Developed for
non-small cell lung carcinoma · colorectal cancer · head and neck squamous cell carcinoma · small cell lung carcinoma · acute myeloid leukemia · B-cell chronic lymphocytic leukemia · breast cancer · cancer
+11 more · COVID-19 · esophageal adenocarcinoma · esophageal squamous cell carcinoma · female reproductive organ cancer · gastroesophageal junction adenocarcinoma · head and neck neoplasm · hematopoietic and lymphoid system neoplasm · myelodysplastic syndrome · non-invasive bladder urothelial carcinoma · oral cavity squamous cell carcinoma · rheumatoid arthritis
Investigated by
AstraZeneca · Innate Pharma · MedImmune LLC · National Cancer Institute (NCI) · Assistance Publique - Hôpitaux de Paris · Assistance Publique Hopitaux De Marseille
+16 more · Barbara Ann Karmanos Cancer Institute · Bladder Cancer Advocacy Network · Canadian Cancer Trials Group · Centre Leon Berard · European Organisation for Research and Treatment of Cancer - EORTC · Hirva Mamdani · Icahn School of Medicine at Mount Sinai · Institut Paoli-Calmettes · Istituto Clinico Humanitas · John Sfakianos · Jules Bordet Institute · Montefiore Medical Center · NRG Oncology · Parexel · SWOG Cancer Research Network · The Netherlands Cancer Institute

Trials 25 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 14 trials
Phase 1 NCT03801902 Oct 2019 → Oct 2021 non-small cell lung carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1 NCT02921685 Nov 2016 → May 2019 hematopoietic and lymphoid system neoplasm Institut Paoli-Calmettes Unknown No outcome recorded
Phase 1 NCT02459301 Sep 2015 → Nov 2017 female reproductive organ cancer Canadian Cancer Trials Group Completed No outcome recorded
Phase 1 NCT01370902 May 2011 → Mar 2014 rheumatoid arthritis Innate Pharma Completed No outcome recorded
Phase 1/25 trials
Phase 1/2 NCT03307941 Jul → Dec 2017 esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma Jules Bordet Institute Withdrawn No outcome recorded
Phase 1/2 NCT02671435 Feb 2016 → Oct 2021 overdue cancer MedImmune LLC Active not recruiting No outcome recorded
Phase 1/2 NCT02643550 Dec 2015 → Mar 2023 head and neck neoplasm Innate Pharma Completed No outcome recorded
Phase 1/2 NCT02557516 Nov 2015 → Oct 2018 B-cell chronic lymphocytic leukemia Innate Pharma Terminated No outcome recorded
Phase 1/2 NCT02331875 Dec 2014 → Dec 2016 oral cavity squamous cell carcinoma Innate Pharma Terminated No outcome recorded
Phase 214 trials
Phase 2 NCT07146230 Sep 2026 → Apr 2028 expected non-small cell lung carcinoma Montefiore Medical Center Not yet recruiting No outcome recorded
Phase 2 NCT06769126 Nov 2025 → Dec 2028 expected small cell lung carcinoma SWOG Cancer Research Network Recruiting No outcome recorded
Phase 2 NCT06503614 Feb 2025 → Dec 2027 expected non-invasive bladder urothelial carcinoma John Sfakianos Recruiting No outcome recorded
Phase 2 NCT06152523 Dec 2023 → Dec 2028 colorectal cancer Assistance Publique - Hôpitaux de Paris Withdrawn No outcome recorded
Phase 2 NCT05903092 Sep 2023 → Oct 2029 expected small cell lung carcinoma Hirva Mamdani Recruiting No outcome recorded
Phase 2 NCT05061550 Apr 2022 → May 2030 expected non-small cell lung carcinoma AstraZeneca Recruiting No outcome recorded
Phase 2 NCT06892223 Dec 2021 → Mar 2025 overdue acute myeloid leukemia, myelodysplastic syndrome Istituto Clinico Humanitas Recruiting No outcome recorded
Phase 2 NCT04307329 Mar 2021 → Jan 2023 breast cancer The Netherlands Cancer Institute Completed No outcome recorded
Phase 2 NCT04145193 Oct 2020 → Mar 2024 colorectal cancer MedImmune LLC Withdrawn No outcome recorded
Phase 2 NCT04333914 Apr 2020 → Jul 2021 COVID-19 Centre Leon Berard Completed No outcome recorded
Phase 32 trials
Phase 3 NCT05221840 Feb 2022 → Sep 2026 expected non-small cell lung carcinoma AstraZeneca Active not recruiting No outcome recorded
Phase 3 NCT04590963 Oct 2020 → May 2022 overdue head and neck squamous cell carcinoma AstraZeneca Active not recruiting No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 28 sources stand behind the page.

FieldValueCited text
Known as Monalizumab “Dose-Ranging and Cohort-Expansion Study of Monalizumab (IPH2201) in Patients with Advanced Gynecologic Malignancies: A Trial of the Canadian Cancer Trials Group (CCTG): IND221.” PMID 31308062 Jul 2019
21

NCT05221840

NCT05061550

NCT04333914

NCT02643550

NCT06769126

NCT06152523

NCT06892223

NCT04307329

NCT03822351

NCT06503614

NCT02921685

NCT03801902

NCT05903092

NCT03794544

NCT02671435

NCT03307941

NCT03833440

NCT04590963

NCT04145193

NCT02557516

NCT07146230

Known as IPH-2201 (ANTI-NKG2A) ChEMBL registry synonym — accepted as the source's own label CHEMBL4297787
Known as IPH2201 “This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK),...” NCT02671435
5

“Dose-Ranging and Cohort-Expansion Study of Monalizumab (IPH2201) in Patients with Advanced Gynecologic Malignancies: A Trial of the Canadian Cancer Trials Group (CCTG): IND221.” PMID 31308062 Jul 2019

“durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201)” NCT05221840

“Monalizumab (IPH2201)” NCT03833440

NCT03088059

NCT02331875

Known as Monalizumab (IPH2201) Monalizumab (IPH2201)NCT03822351
Known as NN-8765 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297787
Known as NN8765-3658 ChEMBL registry synonym — accepted as the source's own label CHEMBL4297787
Known as NNC 0141-0000-0100 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01370902
Action Inhibit “PURPOSE: Monalizumab binds CD94/NKG2A, preventing HLA-E inhibition of tumor lymphocytes.” PMID 31308062 Jul 2019
Modality Monoclonal antibody “Monalizumab is a novel, first-in-class humanized immunoglobulin G4 monoclonal antibody immune checkpoint inhibitor” PMID 36852723 Apr 2023
Route Subcutaneous “Single dose administered subcutaneously (under the skin)” NCT01370902
Target KLRC1 “durvalumab plus monalizumab (anti-NKG2A)” PMID 37707791 Nov 2023