Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Monalizumab · 1 trial · 1 indication
To assess the occurrence of Drug Limited Toxicities (DLTs)
rate of patients in complete or partial response according to RECIST 1.1.
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | Dose escalation of monalizumab in combination with cetuximab |
| Expansion cohort 1 | EXPERIMENTAL | monalizumab + cetuximab expansion cohort |
| Expansion cohort 2 | EXPERIMENTAL | monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers |
| Expansion cohort 3 | EXPERIMENTAL | monalizumab + cetuximab + anti-PD(L)1 |
| Name | Type | Description |
|---|---|---|
| Monalizumab | BIOLOGICAL | - |
| Cetuximab | BIOLOGICAL | - |
| Anti-PD(L)1 | BIOLOGICAL | - |
Main Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically or cytologically-confirmed, HPV (+) or HPV (-) squamous cell carcinoma of the nasopharynx (WHO Type 1), oropharynx, hypopharynx, larynx (supraglottis, glottis, subglottis) or oral cavity. 3. Recurrent or metastatic disease, documented by ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
Monalizumab is an investigational monoclonal antibody being studied for the treatment of head and neck neoplasms, specifically recurrent or metastatic squamous cell carcinoma of the head and neck. It is being evaluated in combination with cetuximab in patients with this condition.
Monalizumab is being developed by Innate Pharma S.A., a biopharmaceutical company. The company's stock is traded under the ticker symbol IPHA.
Monalizumab is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial has been completed, and the drug is no longer in active clinical trials.
Monalizumab has been studied in one clinical trial, identified as NCT02643550. This was a Phase 1 study of Monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The trial has been completed.
Monalizumab is not known to have alternative names. It is a distinct monoclonal antibody being developed by Innate Pharma S.A. for the treatment of head and neck cancer.