N-803
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
- ImmunityBio, Inc. IBRX Source: Company record for ImmunityBio, Inc. (opens in a new tab)
- Indications
- Bladder Cancer; NSCLC Stage IV 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 CompletedFirst trial start 2 Jun 20171 linked trial
- Phase 3 Current stageFirst trial start 2 Jun 20172 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 N-803. Editors add each one with its source.
Filed application
No filed application is on record for N-803. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for N-803.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT06745908ClinicalTrials.gov record for NCT06745908 (opens in a new tab) | Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy | Phase 3 | Recruiting | 507 (estimated) | Sep 2028 (estimated) | No |
| NCT03022825ClinicalTrials.gov record for NCT03022825 (opens in a new tab) | QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer | Phase 2/3 | Active, not recruiting | 190 (actual) | 1 Oct 2024 (actual) | No |
Publications listing NCT03022825 (2), 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 N-803.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- ClinicalTrials.gov NCT06745908 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03022825 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
Record updated .
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