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Also known as Peluntamig (PT217)
Peluntamig · 1 trial · 6 indications
| Arm | Type | Description |
|---|---|---|
| Part A: Dose Escalation | EXPERIMENTAL | A standard 3+3 dose escalation design will be employed. |
| Part B: Dose Expansion | EXPERIMENTAL | Part B cohorts will open after the dose level considered for RDE has been cleared in Parts A, C and D. |
| Part C: Chemotherapy Combination Therapy | EXPERIMENTAL | Part C of the study will include Cohorts C1 and C2, combining Peluntamig (PT217) with chemotherapy. |
| Part D: ICI Combination Therapy | EXPERIMENTAL | In part D, Peluntamig (PT217) will be given in combination with atezolizumab, either alone or in combination with chemotherapy. |
| Name | Type | Description |
|---|---|---|
| Peluntamig (PT217) | DRUG | A bispecific antibody (bsAb) against DLL3 and CD47. |
| Carboplatin + Etoposide | DRUG | Administered per Standard of Care. |
| Paclitaxel. | DRUG | Administered per Standard of Care. |
| Atezolizumab | DRUG | Administered per Standard of Care. |
Key Inclusion Criteria 1. NECs that have transformed from NSCLC are not eligible. Part A: Patients with histologically or cytologically confirmed unresectable advanced or metastatic small cell lung cancer (SCLC), large cell neuroendocrine carcinoma of the lung (LCNEC), or extrapulmonary neuroendocr...
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Peluntamig (PT217) is an investigational small molecule being studied for the treatment of Small Cell Lung Cancer (SCLC). It is also being evaluated in other neuroendocrine carcinomas, including Large Cell Neuroendocrine Cancer, Neuroendocrine Prostate Cancer, and Gastroenteropancreatic Neuroendocrine Carcinoma, as part of the SKYBRIDGE study.
Peluntamig targets DLL3, a protein expressed in neuroendocrine carcinomas. The drug is being studied in patients with tumors that express DLL3, including those with Small Cell Lung Cancer. The ongoing clinical trial is specifically designed for patients with DLL3-expressing neuroendocrine carcinomas.
Peluntamig is being developed by Roche Holding AG, a biopharmaceutical company traded on the OTC market under the ticker RHHBY. Roche is conducting the clinical development program for this investigational drug candidate.
Peluntamig is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting patients to evaluate the safety and efficacy of Peluntamig in neuroendocrine carcinomas.
Peluntamig is being studied in a single Phase 1 clinical trial with the identifier NCT05652686, known as the SKYBRIDGE study. This trial is recruiting 203 patients in the United States with neuroendocrine carcinomas expressing DLL3, including Small Cell Lung Cancer. The study is controlled but not randomized or double-blinded.
Yes, Peluntamig is also known as PT217. Both names refer to the same investigational drug being developed by Roche for the treatment of DLL3-expressing neuroendocrine carcinomas, including Small Cell Lung Cancer. The clinical trial NCT05652686 uses the name Peluntamig (PT217) to identify the drug.