{"entity":{"id":"monalizumab","kind":"drug","name":"Monalizumab","aka":[],"tldr":"Monalizumab is an experimental investigational agent whose form is not stated in the registry from AstraZeneca in phase 3 trials for non-small-cell lung cancer and head and neck squamous cell carcinoma, with its target not yet stated publicly.","summary":"Monalizumab (IPH2201) is an investigational agent whose form is not stated in the registry developed by AstraZeneca and MedImmune. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: Participants will receive IV infusion of monalizumab as stated in arm description. It is the investigational product in 4 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT05221840 (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) and NCT04590963 (Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer), in non-small-cell lung cancer and head and neck squamous cell carcinoma. The largest, NCT05221840, plans to enrol 1051 participants (actual) with primary completion expected 2026-09-30. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Monalizumab","url":"https://clinicaltrials.gov/search?intr=IPH2201"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","head-and-neck"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05221840","nct04590963","nct05061550","nct02671435"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"IPH2201","modality":"antibody (INN stem -mab; form not stated in the registry record)","mechanism":"Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/monalizumab/","neighbours":{"cancer":[{"id":"head-and-neck","kind":"cancer","name":"Head and neck squamous cell carcinoma","route":"/cancers/head-and-neck/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"recurrent-metastatic-hnscc","kind":"cancer","name":"Recurrent or metastatic head and neck squamous cell carcinoma","route":"/cancers/recurrent-metastatic-hnscc/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"trial":[{"id":"nct05221840","kind":"trial","name":"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","route":"/trials/nct05221840/"},{"id":"nct02671435","kind":"trial","name":"A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors","route":"/trials/nct02671435/"},{"id":"nct04590963","kind":"trial","name":"Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer","route":"/trials/nct04590963/"},{"id":"nct05903092","kind":"trial","name":"MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer","route":"/trials/nct05903092/"},{"id":"nct05061550","kind":"trial","name":"Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer","route":"/trials/nct05061550/"},{"id":"nct07146230","kind":"trial","name":"The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2","route":"/trials/nct07146230/"}],"target":[{"id":"hla-e","kind":"target","name":"HLA-E","route":"/targets/hla-e/"},{"id":"klrc1","kind":"target","name":"NKG2A (KLRC1)","route":"/targets/klrc1/"}]}}