Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALT-803 · 3 trials · 3 indications
A continual reassessment method (CRM) design will be used to identify the maximum tolerated dose (MTD) for Phase Ib patients
The phase II portion of the study looks to define the objective response rate (using immune-related RECIST) of ALT-803 added to nivolumab in patients with advanced and unresectable non-small cell lung cancer. Objective response rate will be defined by the best overall response, which is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease, the smallest measurements recorded since the treatment started). The subject's best response assignment will depend on the achievement of both measurement and confirmation criteria.
The period of time required for the concentration or amount of drug in the body to be reduced by one-half.
Apparent volume of distribution is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration.
apparent (extravascular) clearance (CL/F)
maximum observed concentration (Cmax)
time of the observed maximum concentration (Tmax)
area under the plasma concentration curve from time 0 through the last measurable concentration (AUC0-t)
area under the plasma concentration curve from time 0 extrapolated to infinite time (AUC0-inf)
The safety endpoint is the MTD of ALT-803, defined as the dose level below that at which ≥2 of 6 patients experience a DLT.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: ALT-803 6 µg/kg + Nivolumab 3 mg/kg | EXPERIMENTAL | Participants receive ALT-803 6 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 2: ALT-803 10 µg/kg + Nivolumab 3 mg/kg | EXPERIMENTAL | Participants receive ALT-803 10 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 3: ALT-803 15 µg/kg + Nivolumab 3 mg/kg | EXPERIMENTAL | Participants receive ALT-803 15 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Cohort 4: ALT-803 20 µg/kg + Nivolumab 3 mg/kg (RP2D) | EXPERIMENTAL | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV per protocol |
| Arm A: RP2D ALT-803 + Nivolumab (Nivo-naïve) | EXPERIMENTAL | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; Nivolumab-naïve population |
| Arm B: RP2D ALT-803 + Nivolumab (Nivo-progressor) | EXPERIMENTAL | Participants receive ALT-803 20 µg/kg + Nivolumab 3 mg/kg IV; prior Nivolumab exposure |
| Exploratory Arm 1 | NO_INTERVENTION | ALT-803 ± Nivolumab for biomarker analysis only |
| Exploratory Arm 2 | NO_INTERVENTION | ALT-803 ± Nivolumab for biomarker analysis only |
| Group A | EXPERIMENTAL | 1.0 mg/ml ALT-803 |
| Group B | EXPERIMENTAL | 2.0 mg/ml ALT-803 |
| N-803 IV 0.3/0.5 ug/kg | EXPERIMENTAL | - |
| N-803 IV 1.0 ug/kg | EXPERIMENTAL | - |
| N-803 IV 3.0 ug/kg | EXPERIMENTAL | - |
| N-803 IV 6.0 ug/kg | EXPERIMENTAL | - |
| N-803 Subcutaneous 6.0 ug/kg | EXPERIMENTAL | - |
| N-803 Subcutaneous 10.0 ug/kg | EXPERIMENTAL | - |
| N-803 Subcutaneous 15.0 ug/kg | EXPERIMENTAL | - |
| N-803 Subcutaneous 20.0 ug/kg | EXPERIMENTAL | - |
| N-803 Intratumoral 10.0 ug/kg followed by N-803 15.0 ug/kg subcutaneous | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ALT-803 | BIOLOGICAL | ALT-803 administered IV at doses per arm (6, 10, 15, 20 µg/kg) |
| Nivolumab | BIOLOGICAL | Nivolumab administered IV at 3 mg/kg per protocol |
Inclusion Criteria: 1. Histologically or cytologically confirmed diagnosis of NSCLC who present with Stage IIIB/Stage IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) or recurrent disease following radiation therap...
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ALT-803 is an investigational monoclonal antibody being studied for use in oncology, specifically in advanced solid tumors and non-small cell lung cancer. It has been evaluated in Phase 1 clinical trials, including a study in patients with advanced solid tumors and a study combining ALT-803 with nivolumab in pretreated, advanced or metastatic non-small cell lung cancer.
ALT-803 targets the IL-15Rα receptor, which is a receptor in the immune system. By targeting this receptor, ALT-803 is designed to modulate immune responses, which is relevant to its investigation as a cancer treatment. The drug is being developed by ImmunityBio, Inc. for oncology indications.
ALT-803 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol IBRX. The company is conducting clinical research on ALT-803 for oncology indications, including advanced solid tumors and non-small cell lung cancer.
ALT-803 is in Phase 1 clinical development. It has completed three Phase 1 trials, including studies in advanced solid tumors, non-small cell lung cancer, and a pharmacokinetic study in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
ALT-803 has been studied in three completed Phase 1 clinical trials: NCT01946789 in advanced solid tumors, NCT02523469 in non-small cell lung cancer, and NCT03381586 in healthy volunteers. These trials were conducted in the United States and enrolled a total of 67 participants across the studies.
ALT-803 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported for this asset. It is being developed by ImmunityBio, Inc. and is being studied for its effects on the IL-15Rα receptor in oncology indications.