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Also known as REGN4018
Ubamatamab · 4 trials · 13 indications
Incidence of Treatment emergent adverse events according to NCI CTCAE version 6.0 (Safety and Tolerability)
Objective response rate (ORR): Percentage of patients experiencing complete (CR) or partial response (PR) as the best overall radiological response after 3 cycles of ubamatamab in combination with carboplatin-paclitaxel-bevacizumab based on RECIST 1.1 criteria
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| Arm | Type | Description |
|---|---|---|
| Arm 1A | EXPERIMENTAL | - |
| Arm 1B | EXPERIMENTAL | - |
| Arm 1C | EXPERIMENTAL | - |
| Arm 2A | EXPERIMENTAL | - |
| Arm 2B | EXPERIMENTAL | - |
| Arm 2C | EXPERIMENTAL | - |
| Arm A1 | EXPERIMENTAL | - |
| Arm A2 | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Arm C | EXPERIMENTAL | - |
| Arm D | EXPERIMENTAL | - |
| Arms E1/E2 | EXPERIMENTAL | - |
| Carboplatin-paclitaxel-bevacizumab + ubamatamab | EXPERIMENTAL | All participants will receive 3 cycles of the combination carboplatin-paclitaxel-bevacizumab + ubamatamab. After the 3 cycles, they will undergo surgery if it is feasible. Subsequently, they will receive maintenance treatment: * ubamatamab + bevacizumab: for participants with BRCA wild-type and HRD negative tumors and for participants with a disease characterized by a BRCA mutation, or HRD positive status, and experiencing stable disease during the chemotherapy * Olaparib + bevacizumab (standard of care): for participants with a disease characterized by a BRCA mutation, or HRD-positive status, and experiencing complete or partial response during the chemotherapy. |
| Monotherapy | EXPERIMENTAL | REGN4018 administration |
| Combination Therapy | EXPERIMENTAL | REGN4018 and cemiplimab administration |
| Name | Type | Description |
|---|---|---|
| Ubamatamab | DRUG | Administered per the protocol |
| Marlotamig | DRUG | Administered per the protocol |
| Sarilumab | DRUG | Administered per the protocol |
| Bevacizumab | DRUG | Administered per the protocol |
| Cemiplimab | DRUG | Administered per the protocol |
| Fianlimab | DRUG | Administered per the protocol |
| PLD | DRUG | Administered per the protocol |
| REGN10597 | DRUG | Administered per the protocol |
| Chemotherapy | DRUG | Carboplatin + Paclitaxel administered at each cycle of 21 days (in total 3 cycles). |
| GCSF | DRUG | Administered at each cycle during the 3 first cycles of the drug combination (chemotherapy + bevacizumab + ubamatamab). |
| Tocilizumab | DRUG | Administered per the protocol |
Key Inclusion Criteria: 1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC 2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, a...
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Ubamatamab is an investigational monoclonal antibody being developed by Regeneron Pharmaceuticals, Inc. for the treatment of solid tumors. It is in Phase 2 clinical development for non-small cell lung cancer and ovarian cancer, including recurrent and platinum-resistant ovarian cancer. It has not been approved by the FDA and remains under clinical study.
Ubamatamab is being studied in ovarian cancer, including recurrent ovarian cancer and platinum-resistant ovarian cancer, as well as fallopian tube and primary peritoneal cancer. Trials are evaluating it both as a single agent and in combination with other therapies. It is investigational and not approved for any indication.
Ubamatamab is developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is running the clinical program, including studies of ubamatamab alone and in combination with cemiplimab and with marlotamig (REGN7075).
Ubamatamab is in Phase 2 clinical development. Regeneron is running a Phase 2 trial in advanced or metastatic non-small cell lung cancer and a Phase 2 trial in platinum-resistant ovarian cancer, alongside earlier-phase studies. It is investigational and has not received FDA approval.
Ubamatamab is being studied in several trials, including NCT07154290, a Phase 2 study in advanced or metastatic non-small cell lung cancer with and without marlotamig (REGN7075), and NCT06787612, a Phase 2 study in platinum-resistant ovarian cancer. Earlier studies include NCT03564340 in recurrent ovarian cancer and MUC16-expressing cancers and NCT07637851 in first-line ovarian cancer.
Yes, Ubamatamab is also known as REGN4018. The Phase 1 study NCT03564340, which evaluates the drug alone or with cemiplimab in recurrent ovarian cancer and other MUC16-expressing cancers, refers to it as REGN4018 (Ubamatamab). Both names refer to the same Regeneron monoclonal antibody.