Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sipuleucel-T · 1 trial · 2 indications
As assessed via CTCAE v6.0. Dose limiting toxicities will be evaluated according to protocol.
RP2D is defined as the highest dose of N-803 that has an overall DLT rate of less than 33% in total of 6 patients.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Dose level 0 Starting dose: N-803 + SIP-T | EXPERIMENTAL | Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 15 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30. |
| Cohort 1: Dose level -1: N-803 + SIP-T | EXPERIMENTAL | Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 10 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30. |
| Cohort 1: Dose level -2: N-803 + SIP-T | EXPERIMENTAL | Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and 6 mcg/kg SC dose of N-803 24 hours after SIP-T on Day 2, 16, and 30. |
| Cohort 2: N-803 + SIP-T | EXPERIMENTAL | Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and recommended phase 2 dose (RP2D) of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day -5 or 5 days before first SIP-T dose. |
| Cohort 3: N-803 + SIP-T | EXPERIMENTAL | Patients will receive standard dose (\>50 million CD54+ cells) subcutaneous (SC) SIP-T on Day 1, 15 and 29 and RP2D of N-803 24 hours after SIP-T on Day 2, 16, and 30. An additional dose of N-803 will occur on Day 37. |
| Name | Type | Description |
|---|---|---|
| Sipuleucel-T | BIOLOGICAL | Sipuleucel-T is a cellular therapeutic vaccine given in 3 complete doses at 2-week intervals intravenously. |
| N803 | BIOLOGICAL | N-803 is a biologic that is administered subcutaneously in the abdominal area. |
Inclusion Criteria: * Histologically or cytologically confirmed prostate adenocarcinoma. * Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral). * Prior treatment must include either orchiectomy or luteinizing hormone-releasing agoni...
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Sipuleucel-T is an investigational monoclonal antibody being studied for the treatment of prostate cancer, specifically in combination with N-803 for metastatic androgen pathway modulation resistant (mAPMR) prostate cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
Sipuleucel-T is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IBRX. The company is conducting a Phase 1 clinical trial of Sipuleucel-T in combination with N-803 for metastatic prostate cancer.
Sipuleucel-T is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is studying Sipuleucel-T in combination with N-803 for metastatic androgen pathway modulation resistant prostate cancer.
Sipuleucel-T is being studied in one Phase 1 clinical trial with the identifier NCT07756593. The trial is titled 'Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer' and is expected to enroll 30 male participants aged 18 years and older in the United States.
Yes, Sipuleucel-T is also referred to as Sip-T in clinical trial documentation. The Phase 1 trial NCT07756593 uses the abbreviation Sip-T to refer to Sipuleucel-T when describing the combination therapy with N-803 for metastatic prostate cancer.