Recent Updates
Recently added Catalysts

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

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

Clinical trial landscape

AMG 479, Everolimus, Panitumumab · 1 trial · 1 indication

Phase 1 1
NCT01061788A Trial of AMG 479, Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer - QUILT-3.007Advanced Solid Tumors, Non-small Cell Lung Cancer
COMPLETED43 Analytics
PHASE1COMPLETED
A Trial of AMG 479, Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer - QUILT-3.007
Advanced Solid Tumors, Non-small Cell Lung CancerUnlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Frequently asked questions about AMG 479, Everolimus, Panitumumab

What is AMG 479 used for?

AMG 479 is an investigational oncology drug being studied for multiple cancer types, including adenocarcinoma of the pancreas, advanced malignancy, Askin's tumors, breast cancer, advanced solid tumors, and non-small cell lung cancer. It has been evaluated in clinical trials for pancreatic cancer and Ewing's family tumors.

Who makes AMG 479?

AMG 479 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IBRX. The drug is an investigational small molecule oncology therapy.

What phase is AMG 479 in?

AMG 479 has completed Phase 3 clinical development. It remains an investigational drug and is not approved by the FDA. The drug has completed two trials, including a Phase 3 study in metastatic pancreatic cancer.

What clinical trials is AMG 479 in?

AMG 479 has been studied in completed trials including NCT01231347, a Phase 3 study of gemcitabine plus AMG 479 in metastatic adenocarcinoma of the pancreas with 800 participants, and NCT00563680, a Phase 2 study in relapsed or refractory Ewing's family tumors.

Is AMG 479 the same as ganitumab?

AMG 479 is also known by the name ganitumab. It is an investigational drug being developed by ImmunityBio, Inc. for oncology indications including pancreatic cancer and advanced solid tumors.