Monalizumab

Phase 3Monoclonal antibody

AstraZeneca

Monalizumab is one of 140 small molecule programs targeting Small Cell Lung Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

139

Competitors

Pipeline

Status by Indication[3][1]

Indication

Small Cell Lung CancerSuspended

TransplantationRecruiting

Non-Small Cell Lung CancerActive, not recruiting

Solid TumorsActive, not recruiting

Small Cell Lung CancerPhase 2

Suspended

TransplantationPhase 2

Recruiting

Non-Small Cell Lung CancerPhase 3

Active, not recruiting

Solid TumorsPhase 2

Active, not recruiting

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

KN046

JJiangsu Alphamab Biopharmaceuticals Co., Ltd

Phase 3

4 2

Monalizumab

AstraZeneca

Phase 3

5 3

Carboplatin Plus Paclitaxel

Bayer

Phase 3

2 4

HB1801

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Phase 3

2 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Squamous Cell Carcinoma of the Head and Neck

NCT04590963

Q4 2026

Phase 2Recruiting

Transplantation

NCT06892223

Q3 2028

Phase 2Not yet recruiting

Non-Small Cell Lung Cancer

NCT07146230

Q4 2029

Phase 2Recruiting

Small Cell Lung Cancer

NCT06769126

Clinical

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2

Not yet recruiting·MMontefiore Medical Center·Phase 2·NCT07146230·52 enrolled

Testing the Safety of Adding Either Monalizumab (IPH2201) or Oleclumab (MEDI9447) to Durvalumab (MEDI4736) Plus Standard Radiation Therapy for Locally Advanced Non-small Cell Lung Cancer (NSCLC), ARCHON-1 Trial

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT03801902·26 enrolled

Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance

Active, not recruiting·AAssistance Publique Hopitaux De Marseille·Phase 2·NCT03833440·114 enrolled

Show 2 more trials

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT05221840·1,051 enrolled

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)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT05061550·630 enrolled

Small Cell Lung Cancer2 trials

Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT06769126·900 enrolled

MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer

Suspended·HHirva Mamdani·Phase 2·NCT05903092·84 enrolled

Refractory1 trial

Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL

Terminated·IInnate Pharma·Phase 1/2·NCT02557516·22 enrolled

Locally Advanced1 trial

Assessment of Metabolic & Path Response w/ RCT & ImT Before Surgery in Locally Advanced Esoph and Gastro-esoph Jction CA

Withdrawn·JJules Bordet Institute·Phase 1/2·NCT03307941

Squamous Cell Carcinoma1 trial

Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Completed·IInnate Pharma·Phase 1/2·NCT02643550·143 enrolled

7 more indications

Solid Tumors1 trial

A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT02671435·383 enrolled

SARS CoV 2 Infection1 trial

Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection

Completed·CCentre Leon Berard·Phase 2·NCT04333914·19 enrolled

Breast Cancer1 trial

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

Completed·TThe Netherlands Cancer Institute·Phase 2·NCT04307329·12 enrolled

Transplantation1 trial

Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation

Recruiting·IIstituto Clinico Humanitas·Phase 2·NCT06892223·42 enrolled

Stem Cell Transplantation1 trial

Study of a Humanized Antibody Initiated 2 Months After an HLA Matched Allogenic Stem Cell Transplantation

Unknown status·IInstitut Paoli-Calmettes·Phase 1·NCT02921685·18 enrolled

Non Muscle Invasive Bladder Cancer1 trial

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

Recruiting·JJohn Sfakianos·Phase 2·NCT06503614·60 enrolled

Squamous Cell Carcinoma of the Head and Neck1 trial

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

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04590963·370 enrolled

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Monalizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Monalizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Monalizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AstraZeneca

Monalizumab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q3 2028

Q4 2029

Trials by Indication[1]

Non-Small Cell Lung Cancer5 trials

Small Cell Lung Cancer2 trials

Refractory1 trial

Locally Advanced1 trial

Squamous Cell Carcinoma1 trial

Solid Tumors1 trial

SARS CoV 2 Infection1 trial

Breast Cancer1 trial

Transplantation1 trial

Stem Cell Transplantation1 trial

Non Muscle Invasive Bladder Cancer1 trial

Squamous Cell Carcinoma of the Head and Neck1 trial

References

Drug Info

Quick Facts

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