Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SEA-CD70
SEA-CD40 · 1 trial · 2 indications
cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (\<10 millimeter \[mm\] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions.
| Arm | Type | Description |
|---|---|---|
| Melanoma Arm | EXPERIMENTAL | SEA-CD40 + pembrolizumab |
| NSCLC Arm | EXPERIMENTAL | SEA-CD40 + pembrolizumab + pemetrexed + carboplatin |
| Name | Type | Description |
|---|---|---|
| SEA-CD40 | DRUG | Given into the vein (IV; intravenously); schedule is cohort-specific |
| pembrolizumab (KEYTRUDA®) | DRUG | Given by IV; schedule is cohort-specific. |
| pemetrexed | DRUG | Given by IV on Day 1 of each 21-day cycle. |
| carboplatin | DRUG | Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long. |
Inclusion Criteria: * Histologically or cytologically confirmed unresectable malignancy defined as one of the following: * Cohort 1: Relapsed and/or refractory metastatic melanoma * Uveal/ocular melanoma is excluded * Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 t...
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SEA-CD40 is an investigational oncology drug being studied for the treatment of Myelodysplastic Syndrome and Melanoma. It is a small molecule being developed by Pfizer, Inc. (NYSE: PFE). The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.
SEA-CD40 is a small molecule that targets CD40, a protein involved in immune system regulation. By modulating this target, the drug aims to enhance the body's immune response against cancer cells. This mechanism is being explored in clinical trials for conditions like Melanoma and Myelodysplastic Syndrome.
SEA-CD40 is being developed by Pfizer, Inc., a global biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of SEA-CD40 in various oncology indications.
SEA-CD40 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied in clinical trials for the treatment of Myelodysplastic Syndrome and Melanoma, with ongoing research to assess its safety and effectiveness.
SEA-CD40 is being evaluated in two clinical trials. NCT04227847 is a Phase 1 study of SEA-CD70 in patients with Myelodysplastic Syndrome and Acute Myeloid Leukemia, with 178 participants. NCT04993677 is a Phase 2 study of SEA-CD40 given with other drugs in cancers including Melanoma and Non-Small-Cell Lung, with 77 participants.
SEA-CD40 is also known as SEA-CD70. Both names refer to the same investigational drug being developed by Pfizer, Inc. The drug is being studied under different names in various clinical trials, but they represent the same therapeutic agent for oncology indications.