MedPath

Monalizumab

Generic Name
Monalizumab
Drug Type
Biotech
CAS Number
1228763-95-8
Unique Ingredient Identifier
3ZXZ2V0588
Background

Monalizumab has been used in trials studying the treatment of Gynecologic Cancer, Chronic Lymphocytic Leukemia, and Squamous Cell Carcinoma of the Oral Cavity.

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

Phase 2
Not yet recruiting
Conditions
Lung Small Cell Carcinoma, I Subtype
Lung Small Cell Carcinoma, N Subtype
Lung Small Cell Carcinoma, P Subtype
Extensive Stage Lung Small Cell Carcinoma
Lung Small Cell Carcinoma, A Subtype
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Platinum Compound
Procedure: Positron Emission Tomography
Radiation: Thoracic Radiation Therapy
First Posted Date
2025-03-25
Last Posted Date
2025-03-28
Lead Sponsor
SWOG Cancer Research Network
Target Recruit Count
900
Registration Number
NCT06769126

A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

Phase 2
Recruiting
Conditions
Non-Muscle Invasive Bladder Urothelial Carcinoma
Non-muscle Invasive Bladder Cancer
Interventions
First Posted Date
2024-07-16
Last Posted Date
2025-05-04
Lead Sponsor
John Sfakianos
Target Recruit Count
60
Registration Number
NCT06503614
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer

Phase 2
Recruiting
Conditions
Small Cell Lung Cancer
SCLC
Extensive Stage Small Cell Lung Cancer
Interventions
First Posted Date
2023-06-15
Last Posted Date
2025-05-04
Lead Sponsor
Hirva Mamdani
Target Recruit Count
38
Registration Number
NCT05903092
Locations
🇺🇸

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana, United States

🇺🇸

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

🇺🇸

Karmanos Cancer Center (Wayne State University), Detroit, Michigan, United States

and more 1 locations

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

Phase 3
Recruiting
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2022-02-03
Last Posted Date
2025-05-11
Lead Sponsor
AstraZeneca
Target Recruit Count
999
Registration Number
NCT05221840
Locations
🇻🇳

Research Site, Ho Chi Minh, Vietnam

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

Phase 2
Recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2021-09-29
Last Posted Date
2025-05-11
Lead Sponsor
AstraZeneca
Target Recruit Count
630
Registration Number
NCT05061550
Locations
🇹🇷

Research Site, Izmir, Turkey

Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

Phase 3
Active, not recruiting
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
First Posted Date
2020-10-19
Last Posted Date
2025-05-15
Lead Sponsor
AstraZeneca
Target Recruit Count
370
Registration Number
NCT04590963
Locations
🇬🇧

Research Site, Sutton, United Kingdom

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

Phase 2
Completed
Conditions
SARS-CoV-2 (COVID-19) Infection
Advanced or Metastatic Hematological or Solid Tumor
Interventions
Other: Standard of care
Drug: Autophagy inhibitor (GNS651)
First Posted Date
2020-04-03
Last Posted Date
2022-09-30
Lead Sponsor
Centre Leon Berard
Target Recruit Count
19
Registration Number
NCT04333914
Locations
🇫🇷

AP-HP Hôpital Bichat Claude Bernard, Paris, France

🇫🇷

GH Diaconesses Croix Saint Simon, Paris, France

🇫🇷

Institut Gustave Roussy, Villejuif, France

and more 9 locations

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

Phase 2
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2020-03-13
Last Posted Date
2024-10-22
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
12
Registration Number
NCT04307329
Locations
🇳🇱

NKI-AVL, Amsterdam, Netherlands

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

First Posted Date
2019-02-07
Last Posted Date
2024-05-03
Lead Sponsor
Assistance Publique Hopitaux De Marseille
Target Recruit Count
114
Registration Number
NCT03833440
Locations
🇫🇷

Assistance Publique Hopitaux de Marseille, Marseille, France

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

Phase 1
Active, not recruiting
Conditions
Locally Advanced Lung Non-Small Cell Carcinoma
Locally Recurrent Lung Non-Small Cell Carcinoma
Unresectable Lung Non-Small Cell Carcinoma
Stage II Lung Cancer AJCC v8
Stage III Lung Cancer AJCC v8
Interventions
Radiation: Accelerated Hypofractionated Radiation Therapy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging of the Brain with and without Contrast
Radiation: Radiation Therapy
First Posted Date
2019-01-14
Last Posted Date
2025-04-29
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
26
Registration Number
NCT03801902
Locations
🇺🇸

MD Anderson in The Woodlands, Conroe, Texas, United States

🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

🇺🇸

MD Anderson West Houston, Houston, Texas, United States

and more 53 locations
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