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Also known as IPH2201
Monalizumab · 2 trials · 2 indications
To confirm the recommended phase II dose (RP2D) of single agent IPH2201 in patients with advanced/metastatic/recurrent platinum sensitive or resistant high-grade serous carcinoma (HGSC) of ovarian, fallopian tube or peritoneal origin.
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 |
|---|---|---|
| IPH2201 | EXPERIMENTAL | Part 1: 1, 4 or 10mg/kg, IV, 1 hour duration on Day 1 every 2 weeks. Part 2: Patients will receive single agent IPH2201 as above with the actual dose dependent on the outcome of Part 1 |
| 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 |
|---|---|---|
| IPH2201 | DRUG | - |
| Monalizumab | BIOLOGICAL | - |
| Cetuximab | BIOLOGICAL | - |
| Anti-PD(L)1 | BIOLOGICAL | - |
Inclusion Criteria: * Patients must have a histologically and/or cytologically confirmed gynecologic malignancy including high-grade serous ovarian/fallopian tube or peritoneal carcinoma, cervical cancer (squamous cell carcinoma) or endometrial cancer (adenocarcinoma), that is advanced/metastatic/r...
Top 14 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | Luspatercept, Fedratinib, BMS-986158 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, ABBV-744, IMGN632 |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Incyte Corporation | INCY | 8 | PHASE2 | Ruxolitinib, INCB160058, INCB057643, INCA033989, INCA036978 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| GSK plc Sponsored ADR | GSK | 3 | PHASE2 | Momelotinib |
| Eli Lilly and Company | LLY | 2 | PHASE1 | LY3410738, LY5830966 |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Damora Therapeutics, Inc. | DMRA | 2 | PHASE2 | GB2064, DMR-001 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE1 | Revumenib |
Monalizumab is an investigational monoclonal antibody being developed by Innate Pharma S.A. for the treatment of head and neck neoplasms. It is designed as an inhibitor of KLRC1 and has been studied in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. It remains in clinical development and is not an approved therapy.
Monalizumab targets KLRC1, also known as NKG2A, and acts as an inhibitor of this receptor. By binding KLRC1, the antibody is designed to interfere with inhibitory signaling in immune cells. This mechanism is being explored in oncology, specifically in head and neck neoplasms.
Monalizumab is being developed by Innate Pharma S.A., a biopharmaceutical company whose ticker symbol is IPHA. The company is the sponsor associated with the clinical development of this monoclonal antibody in oncology, including head and neck neoplasms.
Monalizumab is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. The Phase 1 study evaluating it in head and neck neoplasms has been completed, and no active trials are currently listed for this asset.
Monalizumab has been evaluated in the Phase 1 trial NCT02643550, titled Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. The trial enrolled 143 patients across the United States and France and is listed as completed.
Monalizumab has been studied in head and neck neoplasms, specifically in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. In the completed Phase 1 trial NCT02643550, it was evaluated in combination with cetuximab. It is investigational and not an approved treatment for this indication.