Monalizumab
ASTRAZENECA PLC AZN · Non-Small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Phase 3
Not recorded
Linked trials
2
From ClinicalTrials.gov
Latest FDA action
None on record
From Drugs@FDA
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- ASTRAZENECA PLC AZN Source: Company record for ASTRAZENECA PLC (opens in a new tab)
- Indications
- Non-Small Cell Lung Cancer; Squamous Cell Carcinoma of the Head and Neck Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 Current stageFirst trial start 2 Oct 20202 linked trials
- Filed Not yet
- Approved Not yet
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Monalizumab. Editors add each one with its source.
Filed application
No filed application is on record for Monalizumab. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Monalizumab.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05221840ClinicalTrials.gov record for NCT05221840 (opens in a new tab)PACIFIC-9 | 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 | Active, not recruiting | 1,051 (actual) | 30 Sep 2026 (estimated) | No |
Publications listing PACIFIC-9 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04590963ClinicalTrials.gov record for NCT04590963 (opens in a new tab)INTERLINK-1 | 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 | 370 (actual) | 11 May 2022 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04590963 (opens in a new tab) |
Posted results on ClinicalTrials.gov for INTERLINK-1
Serious adverse events (Day 1 through 21.4 months (maximum observed duration)): Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2 77 of 246; Placebo Q2W + Cetuximab 400 mg/m^2 27 of 122 Source: ClinicalTrials.gov results for NCT04590963 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing INTERLINK-1 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
No FDA approvals on record for this drug.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Monalizumab.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT05221840 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT04590963 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.