Drug

Monalizumab

In clinical development

ClassNKG2-A/NKG2-B type II integral membrane protein inhibitorEmerging researchLate-stage development

RxNorm1941344 ChEMBLCHEMBL4297787UNII3ZXZ2V0588

Research papers

Active clinical trials

KLRC1

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)

Clinical trial2026-06-23Results expected Q2 2030 · ClinicalTrials.gov

A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy

Clinical trial2026-06-18Results expected Q3 2026 · ClinicalTrials.gov

A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors

Clinical trial2026-06-15Results posted · ClinicalTrials.gov

The Selective Personalized Radio-Immunotherapy for Locally Advanced NSCLC Trial 2 (SPRINT 2)

Clinical trial2026-06-09Results expected Q2 2028 · ClinicalTrials.gov

A Phase 3 Randomized, Double-blind, Multicenter, Global Study of Monalizumab or Placebo in Combination With Cetuximab in Participants With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Previously Treated With an Immune Checkpoint Inhibitor

Clinical trial2026-06-01Results posted · ClinicalTrials.gov

A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) for tReatmenT of Small Cell Lung Cancer (MOZART)

Clinical trial2026-04-29Results expected Q4 2029 · ClinicalTrials.gov

ENHANCE (Elevated NKG2A and HLA-E Amplify NK/CD8 Checkpoint Engagers): A Phase 2 Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

Clinical trial2026-04-08Results expected Q4 2027 · ClinicalTrials.gov

PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Clinical trial2026-03-30Results expected Q4 2028 · ClinicalTrials.gov

Phase I Trial of Radiotherapy Combined With Durvalumab Alone Plus Either Monalizumab or Oleclumab in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)

Clinical trial2025-09-23Results posted · ClinicalTrials.gov

Phase II Clinical Trial to Optimize the Dose of an Anti-NKG2A Monoclonal Antibody (humZ270 MAb, IPH2201) for Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Haploidentical Transplantation with Post- Transplantation Cyclophosphamide

Clinical trial2025-03-01Primary completion · ClinicalTrials.gov

Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors.

Research2024-02-02Journal for immunotherapy of cancer

Monalizumab: inhibiting the novel immune checkpoint NKG2A.

Research2019-10-17Journal for immunotherapy of cancer

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Monalizumab

RxNorm CUI

1941344

ChEMBL ID

CHEMBL4297787

UNII

3ZXZ2V0588

Primary mechanism

NKG2-A/NKG2-B type II integral membrane protein inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

NKG2-A/NKG2-B type II integral membrane protein

KLRC1 · P26715

INHIBITORNKG2-A/NKG2-B type II integral membrane protein inhibitor

Clinical trials

18 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

registered trials across all phases

LATEST COMPLETION 2025

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 18

Phase 12Phase 1 / 24Phase 210Phase 32

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Active, not recruitingPH IIIKey trialAstraZenecan=1,0512030

Active, not recruitingPH IIIAstraZenecan=3702026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Phase I Trial of Radiotherapy Combined With Durvalumab Alone Plus Either Monalizumab or Oleclumab in PD-L1 High Locally Advanced Non-Small Cell Lung Cancer (NSCLC) (ARCHON-1)

CompletedPH INational Cancer Institute (NCI)n=262025

Monalizumab and Trastuzumab In Metastatic HER2-pOSitive breAst Cancer: MIMOSA-trial

CompletedPH IIThe Netherlands Cancer Instituten=122024

Phase 1b/2 Trial of IPH2201 And Cetuximab in Patients With Human Papillomavirus (HPV) (+) and HPV (-) Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

CompletedPH I/IIInnate Pharman=1432023

A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.

CompletedPH IICentre Leon Berardn=192021

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)

CompletedPH IIMedImmune LLCn=842021

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20192024

Most influential

Monalizumab: inhibiting the novel immune checkpoint NKG2A.

Journal for immunotherapy of cancer · 2019 · 225 cites

Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors.

Journal for immunotherapy of cancer · 2024 · 42 cites

Related drugs

1 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Durvalumab

Studied across 2 of the same disease areas as Monalizumab in the shared literature.

2 shared diseases1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials