Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as c264scTCR-IL2
ALT-801 · 2 trials · 5 indications
Number of AEs that occur or worsen after the first dose of study treatment
Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \[RECIST V1.0\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Number of serious adverse events per cohort
Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.
| Arm | Type | Description |
|---|---|---|
| ALT-801 0.04 mg/kg with Cisplatin and Gemcitabine | EXPERIMENTAL | - |
| ALT-801 0.06 mg/kg with Cisplatin and Gemcitabine | EXPERIMENTAL | - |
| ALT-801 0.06 mg/kg with Gemcitabine | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cisplatin | DRUG | Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) |
| Gemcitabine | DRUG | Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course |
| ALT-801 | BIOLOGICAL | Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course |
ENTRY CRITERIA: DISEASE CHARATERISTICS: * Muscle invasive or metastatic urothelial cancer of bladder, ureters, renal pelvis, and urethra * Histologically or cytologically confirmed with a clinical plan that would potentially include cisplatin\* plus gemcitabine systemic therapy or with disease ref...
ALT-801 is an investigational monoclonal antibody being studied in oncology for progressive metastatic malignancies and for transitional cell carcinoma of the bladder, including cancers of the urethra, ureter, and renal pelvis. It has been evaluated in Phase 1 clinical trials, both as a single agent and in combination with cisplatin and gemcitabine.
ALT-801 is being developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. The company has sponsored Phase 1 clinical studies of the antibody in patients with advanced solid tumors and urothelial cancers.
ALT-801 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. Two Phase 1 trials have been completed, one in progressive metastatic malignancies and one in muscle invasive or metastatic urothelial cancer in combination with cisplatin and gemcitabine.
ALT-801 has been studied in two completed Phase 1 trials. NCT01326871 evaluated ALT-801 with cisplatin and gemcitabine in muscle invasive or metastatic urothelial cancer and enrolled 68 patients. NCT00496860 evaluated ALT-801 in progressive metastatic malignancies and enrolled 26 patients. Both trials were conducted in the United States.
ALT-801 was studied in Phase 1 for transitional cell carcinoma of the bladder and related urothelial cancers, including cancers of the urethra, ureter, and renal pelvis. In trial NCT01326871 it was given in combination with cisplatin and gemcitabine to patients with muscle invasive or metastatic urothelial cancer.