Therapy Detail
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| Therapy Name | Cosibelimab |
| Synonyms | |
| Therapy Description |
Unloxcyt (cosibelimab) is a human monoclonal antibody against PD-L1 (CD274), which may block immune checkpoint, and lead to anti-tumor immune response (PMID: 37848259). Unloxcyt (cosibelimab) is FDA approved for use in adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cosibelimab | Unloxcyt | CK-301|CK 301|TG-1501|TG1501|TG 1501|cosibelimab-ipdl | Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 | Unloxcyt (cosibelimab) is a human monoclonal antibody against PD-L1 (CD274), which may block immune checkpoint, and lead to anti-tumor immune response (PMID: 37848259). Unloxcyt (cosibelimab) is FDA approved for use in adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| MSH2 negative | small intestine adenocarcinoma | sensitive | Cosibelimab | Guideline | Actionable | Unloxcyt (cosibelimab) is included in guidelines as systemic therapy (category 2A) for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MSH2, MSH6, MLH1, or PMS2 expression by IHC) (NCCN.org). | detail... |
| MLH1 negative | small intestine adenocarcinoma | sensitive | Cosibelimab | Guideline | Actionable | Unloxcyt (cosibelimab) is included in guidelines as systemic therapy (category 2A) for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MLH1, MSH2, MSH6, or PMS2 expression by IHC) (NCCN.org). | detail... |
| PMS2 negative | small intestine adenocarcinoma | sensitive | Cosibelimab | Guideline | Actionable | Unloxcyt (cosibelimab) is included in guidelines as systemic therapy (category 2A) for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of PMS2, MLH1, MSH2, or MSH6 expression by IHC) (NCCN.org). | detail... |
| MSH6 negative | small intestine adenocarcinoma | sensitive | Cosibelimab | Guideline | Actionable | Unloxcyt (cosibelimab) is included in guidelines as systemic therapy (category 2A) for patients with advanced or metastatic small bowel adenocarcinoma with deficient mismatch repair (dMMR, often defined by the loss of MSH6, MSH2, PMS2, or MLH1 expression by IHC) (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03212404 | Phase I | Cosibelimab | Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers | Active, not recruiting | POL | NZL | FRA | ESP | AUS | 4 |
| NCT03778073 | Phase I | Cosibelimab | Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma | Terminated | USA | 0 |
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