Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALT-801 · 3 trials · 6 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 | - |
| ALT-801 | 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...
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ALT-801 is an investigational monoclonal antibody being studied for progressive metastatic malignancies, metastatic melanoma, and transitional cell carcinoma of the bladder. It has been evaluated in Phase 1 clinical trials in patients with these advanced cancers.
ALT-801 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company has sponsored clinical trials of ALT-801 in oncology indications.
ALT-801 is in Phase 1 clinical development. It has completed Phase 1 trials for progressive metastatic malignancies, metastatic melanoma, and transitional cell carcinoma of the bladder. It remains an investigational drug and is not approved by the FDA.
ALT-801 has completed three Phase 1 trials: NCT00496860 in progressive metastatic malignancies, NCT01029873 in metastatic melanoma with cisplatin, and NCT01326871 in muscle invasive or metastatic urothelial cancer with cisplatin and gemcitabine. All trials were completed in the United States.
ALT-801 is a monoclonal antibody developed by ImmunityBio. No alternative names for ALT-801 have been disclosed in the clinical trial records. It is distinct from other investigational agents and is identified solely by the name ALT-801.