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AMG 479, Everolimus, Panitumumab

Phase 1

Advanced Solid Tumors, Non-small Cell Lung Cancer | Small molecule | Oncology |ImmunityBio, Inc.|Last Updated: Aug 28, 2019

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 Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01061788A Trial of AMG 479, Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer - QUILT-3.007PHASE1 COMPLETED 43 — — Apr 1, 2010Dec 19, 2018Aug 28, 20191 United States
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Study Endpoints
Primary Endpoints
To define the maximal tolerated dose (MTD) and/or recommended phase II dose (RPTD) for the doublet AMG 479 in combination with everolimus in subjects with advanced solid tumors.
3 years
To define the maximal tolerated dose (MTD) and/or recommended phase II dose (RPTD) for the triplet AMG 479 in combination with everolimus and panitumumab in subjects with advanced solid tumors.
3 years
Secondary Endpoints
To describe the toxicity profile seen with these combinations.
3 years
To describe any signs of clinical activity, including response rate and progression free survival associated with these regimens.
3 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Everolimus, AMG 479, PanitumumabEXPERIMENTALDose Escalation Cohort #, Subjects, Everolimus, AMG 479 1. 3-6 subjects, Study drug administered per dose level 2. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479 20 subjects, study drug administered per dose level Dose Escalation, Cohort #, Subjects, Everolimus, AMG 479, Panitumumab 3. 3-6 subjects, Study drug administered per dose level 4. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479, Panitumumab 20 subjects, Study drug administered per dose level NSCLC Cohort Subjects, Everolimus, AMG 479, 20 subjects, Study drug administered per dose level
Interventions
NameTypeDescription
AMG 479, Everolimus, PanitumumabDRUGDose Escalation Cohort #, Subjects, Everolimus, AMG 479 1. 3-6 subjects, Study drug administered per dose level 2. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479 20 subjects, study drug administered per dose level Dose Escalation, Cohort #, Subjects, Everolimus, AMG 479, Panitumumab 3. 3-6 subjects, Study drug administered per dose level 4. 3-6 subjects, Study drug administered per dose level Expanded Cohort Subjects, Everolimus, AMG 479, Panitumumab 20 subjects, Study drug administered per dose level NSCLS Cohort Subjects, Everolimus, AMG 479, 20 subjects, Study drug administered per dose level
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Histologically and/or cytologically confirmed malignant solid tumor that is refractory to standard therapies, or for which no standard therapies exist. Disease must be measurable by RECIST criteria. For the NSCLC expanded cohort only: Only histologically proven adenocarci...

Countries:United States
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