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...
Top 3 of 7 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Bayer | BAYRY | 2 | PHASE1 | BAY 3389934 |
ALT-836 is being studied in combination with gemcitabine for locally advanced or metastatic solid tumors, including locally advanced malignant neoplasms. It has also been studied in sepsis, acute lung injury, and acute respiratory distress syndrome. It is an investigational monoclonal antibody developed by ImmunityBio, Inc.
ALT-836 is developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. The company has sponsored clinical studies of ALT-836 both as a single agent in septic patients and in combination with gemcitabine in patients with advanced solid tumors.
ALT-836 is in Phase 1 development in oncology, where it was studied in combination with gemcitabine. A separate Phase 2 study evaluated ALT-836 in septic patients with acute lung injury or acute respiratory distress syndrome. Both studies are completed, and ALT-836 is investigational rather than approved.
ALT-836 has been evaluated in two completed clinical trials. NCT01325558 was a Phase 1 study of ALT-836 plus gemcitabine in locally advanced or metastatic solid tumors, enrolling 30 patients in the United States. NCT00879606 was a Phase 2 study of ALT-836 in septic patients with acute lung injury or acute respiratory distress syndrome, enrolling 150 patients.
Across its completed studies, ALT-836 has been evaluated in a total of 180 patients. The Phase 1 trial of ALT-836 with gemcitabine in advanced solid tumors enrolled 30 patients, and the Phase 2 trial in septic patients with acute lung injury or acute respiratory distress syndrome enrolled 150 patients.