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AMG 655

Phase 1

Hodgkin's Lymphoma | Small molecule | Oncology |Amgen Inc.|Last Updated: Jan 14, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

AMG 655 · 4 trials · 14 indications

Phase 1 4
NCT00791011Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or VorinostatHodgkin's Lymphoma
COMPLETED33 Analytics
NCT00534027A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung CancerNon-Small Cell Lung Cancer
COMPLETED172 Analytics
NCT00626704Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue SarcomaLocally Advanced or Metastatic, Unresectable Soft Tissue Sarcoma
COMPLETED134 Analytics
NCT00625651Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal CancerMetastatic Colorectal Cancer
COMPLETED202 Analytics
PHASE1COMPLETED
Phase 1b Lymphoma Study of AMG 655 in Combination With Bortezomib or Vorinostat
Hodgkin's LymphomaUnlock trial analytics
PHASE1COMPLETED
A Phase 1b/2 Study of AMG 655 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Non-Small Cell Lung CancerUnlock trial analytics
PHASE1COMPLETED
Phase 1b/2 Study of AMG 655 With Doxorubicin for the First-Line Treatment of Unresectable Soft Tissue Sarcoma
Locally Advanced or Metastatic, Unresectable Soft Tissue SarcomaUnlock trial analytics
PHASE1COMPLETED
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 1: Safety: Subject incidence of treatment emergent adverse events, Dose Limiting Toxicities, the severity of adverse events and clinically significant changes in safety laboratory tests, physical examinations, or vital signs.
Length of Study
Part 2: Objective response rate of AMG 655 Therapy as determined by using IWG criteria at the dose selected in Part 1, in combination with Bortezomib in subjects with mantle cell lymphoma
Length of Study
Progression free survival
Until disease progression
Progression-Free Survival
Length of Study

Secondary Endpoints

Part 2: Overall survival (OS).
Length of study.
Part 2: Progression-Free Survival (PFS).
Length of treatment phase.
Part 2: PK parameters for AMG 655 on a 3 week dosing schedule.
Treatment and follow up phase of study.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 4EXPERIMENTALAMG 655 (intermediate dose) with Vorinostat
Cohort 1EXPERIMENTALAMG 655 (low dose) with Bortezomib
Cohort 2EXPERIMENTALAMG 655 (low dose) with vorinostat
Cohort 5EXPERIMENTALAMG 655 (high dose) with Bortezomib
Cohort 6EXPERIMENTALAMG 655 (high dose) with Vorinostat
Cohort 7EXPERIMENTALPart 2 - Mantle Cell Lymphoma subjects only: AMG 655 at dose TBD with Bortezomib
Cohort 3EXPERIMENTALAMG 655 (intermediate dose) with Bortezomib
Arm 2EXPERIMENTALLow Dose AMG 655 with paclitaxel/carboplatin
Arm 3PLACEBO_COMPARATORPlacebo with paclitaxel/carboplatin
Arm 1EXPERIMENTALAMG 655 High doseplus paclitaxel/carboplatin
AMG 655 Low DoseEXPERIMENTALAMG 655 (low dose) + mFOLFOX6 + Bevacizumab
PlaceboPLACEBO_COMPARATORPlacebo + mFOLFOX6 + Bevacizumab
AMG 655 High DoseEXPERIMENTALAMG 655 (high dose) + mFOLFOX6 + Bevacizumab

Interventions

NameTypeDescription
AMG 655DRUGAMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5).
VorinostatOTHERVorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC).
BortezomibOTHERA dipeptide boronic acid analogue with antineoplastic activity.
AMG 655 placeboOTHERInactive dummy AMG 655 (to maintain blind)
PlaceboOTHERInactive dummy AMG 655 (to maintain blind)
DoxorubicinDRUGAntineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin.
Modified FOLFOX6DRUGCombination treatment comprising oxaliplatin (85 mg/m2), leucovorin (400 mg/m2) and bolus 5-FU (400 mg/m2) and continuous IV 5-FU (2400 mg/m2)\] administered by intravenous infusion once every 14 days (+3 days)
BevacizumabDRUGBevacizumab will be administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle (+3 days).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Part 1: Subjects must have a pathologically confirmed diagnosis of lymphoma that is relapsed or refractory to standard treatment or for which no curative therapy is available. Lymphoma subtypes that are eligible for enrollment include low grade lymphoma, mantle cell lymphoma, ...

Countries:United States
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Frequently asked questions about AMG 655

What is AMG 655 used for?

AMG 655 is an investigational oncology drug being studied for the treatment of Hodgkin's lymphoma, metastatic colorectal cancer, locally advanced or metastatic unresectable soft tissue sarcoma, and non-small cell lung cancer. It is being developed by Amgen Inc. and is currently in Phase 1 clinical trials.

What does AMG 655 target?

AMG 655 is a small molecule being developed by Amgen Inc. for oncology indications. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied in combination with other agents for various cancer types.

Who makes AMG 655?

AMG 655 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 1 clinical development for multiple oncology indications, including non-small cell lung cancer and metastatic colorectal cancer.

What phase is AMG 655 in?

AMG 655 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed for its use in non-small cell lung cancer, metastatic colorectal cancer, soft tissue sarcoma, and lymphoma.

What clinical trials is AMG 655 in?

AMG 655 has been studied in several completed Phase 1 clinical trials. These include NCT00534027 for non-small cell lung cancer, NCT00625651 for metastatic colorectal cancer, NCT00626704 for soft tissue sarcoma, and NCT00791011 for lymphoma. The trials enrolled a total of 202 participants.

Is AMG 655 the same as other drugs?

AMG 655 is also known by its development code AMG 655. No other alternative names have been established for this drug in the available clinical trial information. It is being developed by Amgen Inc. for various oncology indications.