Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
N-803 · 5 trials · 5 indications
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST
Measured by RECIST v1.1 and iRECIST and survival status
Measured by the CA-125 result
Response Criteria in Solid Tumors (RECIST) V1.1
Incidence of SAEs and overall AEs coded in MedDRA
| Arm | Type | Description |
|---|---|---|
| Cohort A: Experimental Arm | EXPERIMENTAL | 3-week cycles. N803, Tislelizumab, and Docetaxel will be administered on Cycle 1 and 2. N803 and Tislelizumab will be administered on Cycle 3 and onward until end of study. |
| Cohort A: Control Arm | ACTIVE_COMPARATOR | The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV. |
| Cohort B: Experimental Arm | EXPERIMENTAL | 3-week cycles. N803, prior failed checkpoint inhibitor, and Docetaxel will be administered on Cycle 1 and 2. N803 and prior failed checkpoint inhibitor will be administered on Cycle 3 and onward until end of study. |
| Cohort B: Control Arm | ACTIVE_COMPARATOR | The control arm treatment regimen will consist of repeated 3-week cycles with a ± 3-day window for each visit of Docetaxel 75 mg/m2 IV. |
| N-803 | EXPERIMENTAL | All patients will be in this arm. |
| All subjects | EXPERIMENTAL | Gemcitabine plus M-CENK plus N-803 |
| Cohort A Control Treatment Arm | ACTIVE_COMPARATOR | SBRT + gemcitabine + nab-paclitaxel |
| Cohort A Experimental Treatment Arm 1 | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin HCl + N-803 |
| Cohort A Experimental Treatment Arm 2 | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK |
| Cohort B Control Treatment Arm | ACTIVE_COMPARATOR | Irinotecan liposome + 5-FU/leucovorin |
| Cohort B Experimental Treatment Arm | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel+ aldoxorubicin HCl + N-803 + PD-L1 t-haNK |
| Cohort C Experimental Treatment Arm | EXPERIMENTAL | SBRT + cyclophosphamide + gemcitabine + nab-paclitaxel + aldoxorubicin + N-803 + PD-L1 t-haNK |
| Healthy Subjects | EXPERIMENTAL | Subjects will be scheduled for first apheresis collection on study Day 1. All subjects will receive N-803 at a fixed dose of 1 mg by subcutaneous (SC) injection 4 to 5 days prior to the second apheresis collection. The study day for N-803 administration will be determined based on the planned date of the second apheresis collection. |
| Name | Type | Description |
|---|---|---|
| N-803 | DRUG | N-803 1.2 mg SC |
| Tislelizumab | DRUG | Tislelizumab 200 mg IV |
| Docetaxel | DRUG | Docetaxel 75 mg/m2 IV |
| Prior failed checkpoint inhibitor | DRUG | Previously failed checkpoint inhibitor |
| N-803 (IL-15 Superagonist) | DRUG | N-803 administered subcutaneously. |
| Gemcitabine | DRUG | Dose: 800 mg/m2 intravenously (IV) Frequency: administered on Day 1, Day 8, and Day 15 of each cycle (every 4 weeks) |
| M-CENK | BIOLOGICAL | Dose: 0.15 to 0.75 × 109 cells per infusion intravenously (IV) Frequency: administered on Day 1 of each cycle as long as M-CENK cells are available. |
| Aldoxorubicin HCl | DRUG | Aldoxorubicin hydrochloride |
| PD-L1 t-haNK | BIOLOGICAL | PD-L1 t-haNK suspension for infusion |
| Nab-paclitaxel | DRUG | Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca\[3,4\]benz\[1,2-b\]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin |
| Cyclophosphamide | DRUG | 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate |
| 5-Fluorouracil | DRUG | 5-fluoro-2,4 (1H,3H)-pyrimidinedione |
| Leucovorin | DRUG | L-Glutamic acid, N-\[4-\[\[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl\]amino\]benzoyl\]-, calcium salt |
| SBRT | PROCEDURE | Stereotactic Body Radiation Therapy |
| Irinotecan liposome | DRUG | Irinotecan hydrochloride trihydrate is (S)-4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo1H-pyrano\[3',4':6,7\]-indolizino\[1,2-b\]quinolin-9-yl-\[1,4'bipiperidine\]-1'-carboxylate, monohydrochloride, trihydrate |
Eligibility Criteria: Women and men of all races and ethnic groups are eligible for this trial. Cohort A Inclusion Criteria: 1. Age ≥ 18 years old. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Commit...