Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ALT-836
ALT-836 in combination with gemcitabine · 2 trials · 5 indications
Number and severity of treatment related AEs that occur or worsen after the first dose of study treatment
Number of participants with complete response, partial response or stable disease
Number of participants with 9-month, 12-month, 18-month, 24-month, 30-month or 36-month progression-free survival
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Participants will be randomized to receive ALT-836. |
| 2 | PLACEBO_COMPARATOR | Patients will be randomized to receive placebo. |
| Name | Type | Description |
|---|---|---|
| ALT-836 | DRUG | In the first part of this study, recombinant chimeric anti-tissue factor antibody ALT-836 was administered as a single dose (0.06 mg/Kg) via intravenous infusion over 15 minutes. In the second part of this study, up to four doses (0.06 mg/Kg) of ALT-836 will be administered via intravenous infusion over 15 minutes. |
| Placebo | DRUG | In the first part of this study, a single dose of Placebo was administered via intravenous infusion over 15 minutes. In the second part of this study, up to four doses of Placebo will be administered via intravenous infusion over 15 minutes. |
| ALT-836 in combination with gemcitabine | BIOLOGICAL | Study participants will receive up to four courses of a 28-day biochemotherapy with the study drug (ALT-836) and gemcitabine. Each treatment course consists of five doses of ALT-836 (on Day 1, 4, 8, 15 and 22) and three doses of gemcitabine (Day 1, 8 and 15). Participants with persistent responses will receive additional two cycles, three doses each, of standard of care gemcitabine therapy. |
INCLUSION CRITERIA: 1. Suspected or proven infection 2. Hypoxemia: PaO2/FiO2is ≤300 mm Hg 3. Bilateral infiltrates consistent with pulmonary edema 4. Positive-pressure mechanical ventilation through an endotracheal tube 5. No clinical evidence of left atrial hypertension to explain bilateral infilt...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 1 | PHASE2 | Nogapendekin alfa inbakicept |
| Bluejay Diagnostics, Inc. | BJDX | 2 | - | Undisclosed |
| CytoSorbents Corporation | CTSO | 1 | - | Undisclosed |
| Danaher Corporation | DHR | 3 | - | Undisclosed |
| Spectral AI, Inc. Class A | MDAI | 1 | N/A | Undisclosed |
ALT-836 is an investigational small molecule being studied for the treatment of sepsis, specifically in patients with acute lung injury or acute respiratory distress syndrome. It is currently in Phase 2 clinical development and has not been approved by the FDA.
ALT-836 is an anti-tissue factor (TF) antibody, meaning it targets tissue factor, a protein involved in coagulation and inflammation. By blocking tissue factor, it may help reduce the harmful effects of sepsis on the lungs and other organs.
ALT-836 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with sepsis.
ALT-836 is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug, meaning it has not yet received regulatory approval for any use.
ALT-836 has been studied in one completed Phase 2 clinical trial, identified as NCT00879606. This trial enrolled 150 patients with sepsis and acute lung injury or acute respiratory distress syndrome, and it was conducted in the United States.
Yes, ALT-836 is also known as an anti-TF antibody, which refers to its mechanism of targeting tissue factor. This name is used in clinical trial descriptions to identify the drug's action against tissue factor in sepsis patients.