Drugs / Monalizumab
Monalizumab
also known as
IPH2201 · IPH-2201 (ANTI-NKG2A) · Monalizumab (IPH2201) · NN-8765 · NN8765-3658 · NNC 0141-0000-0100
Monoclonal antibody targets KLRC1
Trials 25
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03801902 | Oct 2019 → Oct 2021 | non-small cell lung carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT02921685 | Nov 2016 → May 2019 | hematopoietic and lymphoid system neoplasm | Institut Paoli-Calmettes | Unknown | No outcome recorded |
| Phase 1 | NCT02459301 | Sep 2015 → Nov 2017 | female reproductive organ cancer | Canadian Cancer Trials Group | Completed | No outcome recorded |
| Phase 1 | NCT01370902 | May 2011 → Mar 2014 | rheumatoid arthritis | Innate Pharma | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT03307941 | Jul → Dec 2017 | esophageal adenocarcinoma, esophageal squamous cell carcinoma, gastroesophageal junction adenocarcinoma | Jules Bordet Institute | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT02671435 | Feb 2016 → Oct 2021 overdue | cancer | MedImmune LLC | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT02643550 | Dec 2015 → Mar 2023 | head and neck neoplasm | Innate Pharma | Completed | No outcome recorded |
| Phase 1/2 | NCT02557516 | Nov 2015 → Oct 2018 | B-cell chronic lymphocytic leukemia | Innate Pharma | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02331875 | Dec 2014 → Dec 2016 | oral cavity squamous cell carcinoma | Innate Pharma | Terminated | No outcome recorded Stop: Enrollment |
| Phase 214 trials | ||||||
| Phase 2 | NCT07146230 | Sep 2026 → Apr 2028 expected | non-small cell lung carcinoma | Montefiore Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06769126 | Nov 2025 → Dec 2028 expected | small cell lung carcinoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 2 | NCT06503614 | Feb 2025 → Dec 2027 expected | non-invasive bladder urothelial carcinoma | John Sfakianos | Recruiting | No outcome recorded |
| Phase 2 | NCT06152523 | Dec 2023 → Dec 2028 | colorectal cancer | Assistance Publique - Hôpitaux de Paris | Withdrawn | No outcome recorded |
| Phase 2 | NCT05903092 | Sep 2023 → Oct 2029 expected | small cell lung carcinoma | Hirva Mamdani | Recruiting | No outcome recorded |
| Phase 2 | NCT05061550 | Apr 2022 → May 2030 expected | non-small cell lung carcinoma | AstraZeneca | Recruiting | No outcome recorded |
| Phase 2 | NCT06892223 | Dec 2021 → Mar 2025 overdue | acute myeloid leukemia, myelodysplastic syndrome | Istituto Clinico Humanitas | Recruiting | No outcome recorded |
| Phase 2 | NCT04307329 | Mar 2021 → Jan 2023 | breast cancer | The Netherlands Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT04145193 | Oct 2020 → Mar 2024 | colorectal cancer | MedImmune LLC | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04333914 | Apr 2020 → Jul 2021 | COVID-19 | Centre Leon Berard | Completed | No outcome recorded |
| Phase 2 | NCT03833440 | Oct 2019 → Oct 2024 | non-small cell lung carcinoma | Assistance Publique Hopitaux De Marseille | Unknown | No outcome recorded |
| Phase 2 | NCT03794544 | Mar 2019 → Jan 2021 | non-small cell lung carcinoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT03822351 | Dec 2018 → Jul 2023 | non-small cell lung carcinoma | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT03088059 | Nov 2017 → Jun 2025 | head and neck squamous cell carcinoma | European Organisation for Research and Treatment of Cancer - EORTC | Unknown | No outcome recorded |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT05221840 | Feb 2022 → Sep 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04590963 | Oct 2020 → May 2022 overdue | head and neck squamous cell carcinoma | AstraZeneca | Active not recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2024-09-09 | Innate Pharma | Results Monalizumab data from NeoCOAST-2 Phase 2 study in early-stage NSCLC presented at the WCLC 2024 innate-pharma.com ↗
Treatment in Arm 2 showed manageable safety profile and no impact on surgical rate. |
| 2022-08-01 | Innate Pharma | Results Innate Pharma provides update on AstraZeneca-sponsored Interlink-1 Phase 3 study innate-pharma.com ↗ |
| 2022-03-28 | AstraZeneca | Results AstraZeneca aims to transform the oncology treatment landscape with diverse early pipeline and novel combinations at AACR astrazeneca.com ↗
A presentation from the NeoCOAST randomised Phase II trial in resectable, early-stage non-small cell lung cancer will highlight improved disease responses with novel Imfinzi (durvalumab) combinations including with oleclumab, an anti-CD73 monoclonal antibody, and with monalizumab 1 , an anti-NKG2A checkpoint inhibitor, when compared to Imfinzi alone. |
| 2021-12-09 | Innate Pharma | Results Monalizumab combined with cetuximab and durvalumab demonstrates anti-tumor activity in first-line recurrent or metastatic head and neck cancer at ESMO Immuno-Oncology 2021 Congress innate-pharma.com ↗
After a median follow-up of 16.3 months, preliminary data suggest anti-tumor activity in the triplet of monalizumab, cetuximab and durvalumab in first-line treatment of R/M HNSCC. |
| 2021-09-17 | Innate Pharma | Results Monalizumab data from COAST trial presented at ESMO Congress 2021 innate-pharma.com ↗
We’re pleased to see the monalizumab COAST results, particularly the improved clinical outcomes for patients with unresectable, Stage III non-small cell lung cancer |
| 2021-09-17 | AstraZeneca | Results Imfinzi combined with novel immunotherapies improved clinical outcomes for patients with unresectable, Stage III non-small cell lung cancer astrazeneca.com ↗
The 10-month PFS rate was 64.8% for the durvalumab plus oleclumab combination and 72.7% for durvalumab plus monalizumab, versus 39.2% with durvalumab alone. |
| 2020-05-14 | Innate Pharma | Results Innate Pharma to present new efficacy data for monalizumab in combination with cetuximab in Head and Neck Cancer at the ASCO20 Virtual Scientific Program innate-pharma.com ↗
Phase II expansion cohort of “IO-pretreated patients” demonstrates 20% overall response rate |
| 2019-10-01 | Innate Pharma | Results Innate Pharma presents early clinical data on IPH5401 and monalizumab at the ESMO 2019 congress innate-pharma.com ↗
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announced that new data on IPH5401 and monalizumab were presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain. |
| 2018-11-30 | Innate Pharma | Results Innate Pharma announces publication of monalizumab research in the prestigious “Cell” journal widening the horizon of immune checkpoint inhibitors innate-pharma.com ↗
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announced the publication of data demonstrating the potential of monalizumab, an anti-NKG2A antibody, which could extend cancer immunotherapies to NK cell-based treatments. |
| 2018-11-12 | Innate Pharma | Results SITC 2018: further analyses of the Phase II study of the combination of monalizumab and cetuximab in head and neck patients show encouraging survival data in both subgroups of IO-naïve and IO-pretreated SCCHN patients innate-pharma.com ↗ |
| 2018-10-20 | Innate Pharma | Results Innate Pharma announces Phase II results from monalizumab and cetuximab combination in head and neck cancer at the ESMO 2018 Congress innate-pharma.com ↗ |
| 2018-06-04 | Innate Pharma | Results Clinical data from ongoing Phase I dose escalation and expansion study of monalizumab and Imfinzi® (durvalumab) in colorectal cancer patients presented at 2018 ASCO annual meeting innate-pharma.com ↗ |
| 2018-05-17 | Innate Pharma | Results Preliminary data from a Phase I dose escalation and expansion study of monalizumab and Imfinzi® (durvalumab) show anti-tumor activity in colorectal cancer patients innate-pharma.com ↗
The data also showed a manageable toxicity profile. |
| 2018-04-17 | Innate Pharma | Results Preliminary data suggest promising anti-tumor activity of the combination of monalizumab and cetuximab in patients with platinum pretreated SCCHN innate-pharma.com ↗
8 partial responses (PR) among 26 patients evaluable for efficacy – predefined number of responses needed to declare the trial result positive has been reached |
| 2018-04-17 | Innate Pharma | Results New preclinical data further support ongoing programs and highlight next generation of immunotherapies innate-pharma.com ↗
Blockade of NKG2A potentiated cetuximab induced antibody-dependent cell-mediated cytotoxicity (ADCC) towards SCCHN cell lines. |
| 2017-09-11 | Innate Pharma | Results ICI conference 2017: new preclinical data further strengthen the rationale of IPH5401 and monalizumab for cancer treatments and in combination with anti-PD-1/PD-L1 innate-pharma.com ↗ |
| 2017-03-02 | Innate Pharma | Results Clinical and preclinical data on monalizumab to be presented at AACR annual meeting 2017 innate-pharma.com ↗
In this study, monalizumab plus cetuximab were well tolerated with no additional safety concerns compared to monalizumab or cetuximab alone. |
| 2016-11-30 | Innate Pharma | Results First clinical data for monalizumab as a single agent in cancer patients show favorable safety profile innate-pharma.com ↗
The data showed that monalizumab was well tolerated in this patient population, with no dose-limiting toxicities observed. |
| 2016-04-18 | Innate Pharma | Results New data presented at AACR support the rationale for combination treatment with monalizumab and durvalumab innate-pharma.com ↗
Treatment with combination of NKG2A and PD-1 checkpoint inhibitors resulted in significantly enhanced anti-tumor responses. |
| 2011-02-28 | Innate Pharma | Regulatory Innate Pharma receives a milestone payment for IPH2201, a monoclonal antibody licensed to Novo Nordisk A/S innate-pharma.com ↗
Innate Pharma (the “Company” - Euronext Paris: FR0010331421 – IPH) announces that a European trial application has been filed by Novo Nordisk A/S for IPH2201 (NN8765). |
All press releases naming this drug 37 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Monalizumab | “Dose-Ranging and Cohort-Expansion Study of Monalizumab (IPH2201) in Patients with Advanced Gynecologic Malignancies: A Trial of the Canadian Cancer Trials Group (CCTG): IND221.” PMID 31308062 ↗ Jul 2019 |
| Known as | IPH-2201 (ANTI-NKG2A) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297787 ↗ |
| Known as | IPH2201 | “This is a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK),...” NCT02671435 ↗5“Dose-Ranging and Cohort-Expansion Study of Monalizumab (IPH2201) in Patients with Advanced Gynecologic Malignancies: A Trial of the Canadian Cancer Trials Group (CCTG): IND221.” PMID 31308062 ↗ Jul 2019 “durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201)” NCT05221840 ↗ “Monalizumab (IPH2201)” NCT03833440 ↗ |
| Known as | Monalizumab (IPH2201) | “Monalizumab (IPH2201)” NCT03822351 ↗ |
| Known as | NN-8765 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297787 ↗ |
| Known as | NN8765-3658 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297787 ↗ |
| Known as | NNC 0141-0000-0100 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01370902 ↗ |
| Action | Inhibit | “PURPOSE: Monalizumab binds CD94/NKG2A, preventing HLA-E inhibition of tumor lymphocytes.” PMID 31308062 ↗ Jul 2019 |
| Modality | Monoclonal antibody | “Monalizumab is a novel, first-in-class humanized immunoglobulin G4 monoclonal antibody immune checkpoint inhibitor” PMID 36852723 ↗ Apr 2023 |
| Route | Subcutaneous | “Single dose administered subcutaneously (under the skin)” NCT01370902 ↗ |
| Target | KLRC1 | “durvalumab plus monalizumab (anti-NKG2A)” PMID 37707791 ↗ Nov 2023 |