Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ubamatamab · 4 trials · 10 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
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Escalation Phase
Dose Expansion Phase
Dose Expansion Phase
| 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 | - |
| 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 |
| REGN7075 | 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 |
| 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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