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ALT-801

Phase 1

Progressive Metastatic Malignancies | Monoclonal antibody | Oncology |ImmunityBio, Inc.|Last Updated: Jul 22, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00496860Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic MalignanciesPHASE1 COMPLETED 26May 1, 2007Oct 1, 2009Jul 22, 20134 United States
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Study Endpoints
Primary Endpoints
The Safety and Toxicity of ALT-801 in Patients With Progressive Metastatic Malignancies
18 months

Number of serious adverse events per cohort

The Maximum-tolerated Dose (MTD) of ALT-801
18 months

Number of dose limiting toxicities (DLTs). A DLT is a toxicity that results in patient withdrawal from the study as defined in the protocol.

Secondary Endpoints
Clinical Antitumor Response to ALT-801
24 months
ALT-801 Induced Cell-mediated Immune Responses
24 months
Immunogenicity of ALT-801
24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ALT-801BIOLOGICALDose escalation (0.015 mg/kg, 0.04 mg/kg, 0.08 mg/kg, 0.12 mg/kg, 0.14 mg/kg, 0.16 mg/kg), intravenous infusions, two treatment cycle, each cycle with 4 daily on-dose infusion, 10 days rest between cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

ENTRY CRITERIA: DISEASE CHARACTERISTICS: * Locally advanced or metastatic malignancies * Histologically or cytologically confirmed * Evaluable * Surgically and medically incurable * Not responding to standard therapy or no other standard therapy exists * Human leukocyte antigen (HLA)-A2.1/p53 posi...

Countries:United States
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