Monalizumab
drug drugOn this page
Also known as Iph-2201IPH-2201 (ANTI-NKG2A)Iph2201NN-8765NN8765
Summary
Monalizumab (CHEMBL4297787) is a phase-3 clinical-stage antibody targeting KLRC1; indicated across 13 conditions including squamous cell carcinoma and non-small cell lung carcinoma.
At a glance
- Status: Max clinical phase 3 (not approved)
- Modality: Antibody
- Targets: 1 (KLRC1)
- Indications: 13 conditions
- Clinical trials: 24
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4297787 |
| Name | Monalizumab |
| Type | Antibody |
| Max phase | 3 |
Also known as: Iph-2201, IPH-2201 (ANTI-NKG2A), Iph2201, IPH2201, Monalizumab, NN-8765, NN8765, MONALIZUMAB
Targets
Targets
Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).
| Gene | Target | Action | pAffinity | Cancer dependency | UniProt |
|---|---|---|---|---|---|
| KLRC1 | killer cell lectin like receptor C1 (CD159a) | Binding | 10.57 | 0% | P26715 |
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
Aggregated over 1 target gene(s): KLRC1.
Top Reactome pathways
1 total, by targets touching each:
| Pathway | Targets | Genes |
|---|---|---|
| Immunoregulatory interactions between a Lymphoid and a non-Lymphoid cell | 1 | KLRC1 |
Dominant GO biological processes
| GO term | Targets |
|---|---|
| negative regulation of T cell mediated cytotoxicity | 1 |
| stimulatory C-type lectin receptor signaling pathway | 1 |
| adaptive immune response | 1 |
| CD8-positive, gamma-delta intraepithelial T cell differentiation | 1 |
| natural killer cell inhibitory signaling pathway | 1 |
| cell surface receptor signaling pathway | 1 |
| regulation of natural killer cell activation | 1 |
| innate immune response | 1 |
| negative regulation of natural killer cell mediated cytotoxicity | 1 |
| positive regulation of natural killer cell mediated cytotoxicity | 1 |
| immune system process | 1 |
| immune response-regulating cell surface receptor signaling pathway | 1 |
| regulation of natural killer cell mediated cytotoxicity | 1 |
Indications & clinical
Indications
12 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.
| Disease (in trials) | Phase | MONDO | EFO |
|---|---|---|---|
| squamous cell carcinoma | 3 | MONDO:0005096 | EFO:0000707 |
| non-small cell lung carcinoma | 3 | MONDO:0005233 | EFO:0003060 |
| head and neck squamous cell carcinoma | 3 | MONDO:0010150 | EFO:0000181 |
| breast neoplasm | 2 | MONDO:0021100 | MONDO:0007254 |
| neoplasm | 2 | MONDO:0005070 | EFO:0000616 |
| severe acute respiratory syndrome | 2 | MONDO:0005091 | MONDO:0100096 |
| small cell lung carcinoma | 2 | MONDO:0008433 | EFO:0000702 |
| colorectal neoplasm | 2 | MONDO:0005335 | MONDO:0005575 |
| B-cell chronic lymphocytic leukemia | 1 | MONDO:0004948 | EFO:0000095 |
| upper aerodigestive tract neoplasm | 1 | MONDO:0005398 | EFO:0004284 |
| oral cavity squamous cell carcinoma | 1 | MONDO:0004958 | EFO:0000199 |
| female reproductive system neoplasm | 1 | MONDO:0021148 | MONDO:0021148 |
1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 24.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 14 |
| PHASE1/PHASE2 | 5 |
| PHASE1 | 3 |
| PHASE3 | 2 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04590963 | PHASE3 | ACTIVE_NOT_RECRUITING | Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer |
| NCT05221840 | PHASE3 | ACTIVE_NOT_RECRUITING | 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 |
| NCT02671435 | PHASE1/PHASE2 | ACTIVE_NOT_RECRUITING | A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors |
| NCT03833440 | PHASE2 | ACTIVE_NOT_RECRUITING | Precision Immuno-Oncology for Advanced Non-small Cell Lung Cancer Patients With PD-1 ICI Resistance |
| NCT05061550 | PHASE2 | RECRUITING | Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer |
| NCT05903092 | PHASE2 | RECRUITING | MOnaliZumab in Combination With durvAlumab (MEDI4736) for tRreatmenT of Small Cell Lung Cancer |
| NCT06503614 | PHASE2 | RECRUITING | A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer |
| NCT06769126 | PHASE2 | RECRUITING | Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study |
| NCT06892223 | PHASE2 | RECRUITING | Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation |
| NCT07146230 | PHASE2 | NOT_YET_RECRUITING | The Selective Personalized Radio-Immunotherapy for Locally Advanced Non-Small Cell Lung Cancer Trial 2 |
| NCT02331875 | PHASE1/PHASE2 | TERMINATED | Efficacy Study of Pre-operative IPH2201 in Patients With Squamous Cell Carcinoma of the Oral Cavity |
| NCT02557516 | PHASE1/PHASE2 | TERMINATED | Combination Study of IPH2201 (Monalizumab) With Ibrutinib in Relapsed, Refractory or Previously Untreated CLL |
| NCT02643550 | PHASE1/PHASE2 | COMPLETED | Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck |
| NCT03088059 | PHASE2 | UNKNOWN | Biomarker-based Study in R/M SCCHN |
| NCT03307941 | PHASE1/PHASE2 | WITHDRAWN | Assessment of Metabolic & Path Response w/ RCT & ImT Before Surgery in Locally Advanced Esoph and Gastro-esoph Jction CA |
| NCT03794544 | PHASE2 | COMPLETED | Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer |
| NCT03822351 | PHASE2 | COMPLETED | Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC |
| NCT04145193 | PHASE2 | WITHDRAWN | Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC |
| NCT04307329 | PHASE2 | COMPLETED | Monalizumab and Trastuzumab In Metastatic HER2-pOSitive breAst Cancer: MIMOSA-trial |
| NCT04333914 | PHASE2 | COMPLETED | Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection |
| NCT06152523 | PHASE2 | WITHDRAWN | Monalizumab and MEDI5752 in Patients With MSI and/or dMMR Metastatic Cancer |
| NCT02459301 | PHASE1 | COMPLETED | A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies |
| NCT02921685 | PHASE1 | UNKNOWN | Study of a Humanized Antibody Initiated 2 Months After an HLA Matched Allogenic Stem Cell Transplantation |
| NCT03801902 | PHASE1 | COMPLETED | 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 |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).