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BIIB022

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |Biogen Inc.|Last Updated: Jan 9, 2017

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

BIIB022 · 2 trials · 2 indications

Phase 1 2
NCT00956436Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma
COMPLETED40 Analytics
NCT00555724Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid TumorsSolid Tumors
COMPLETED40 Analytics
PHASE1COMPLETED
Sorafenib With BIIB022 in Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma
NCT0095643640
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PHASE1COMPLETED
Phase 1 Study of BIIB022 (Anti-IGF-1R Monoclonal Antibody) in Relapsed/Refractory Solid Tumors
Solid Tumors
NCT0055572440
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Study Endpoints

Primary Endpoints

To evaluate the safety and tolerability of BIIB022 given once every 3 weeks in combination with sorafenib in subjects with advanced HCC.
6 months
To evaluate the safety and tolerability of BIIB022
ongoing

Secondary Endpoints

To evaluate the PK profile of BIIB022 and sorafenib in this study population
6 months
To assess the anti-tumor response in this study population
6 months
To evaluate pharmacokinetics
ongoing
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sorafenib MonotherapyEXPERIMENTALSorafenib Monotherapy
Sorafenib with BIIB022EXPERIMENTALSorafenib with BIIB022
BIIB022EXPERIMENTAL -

Interventions

NameTypeDescription
BIIB022DRUGIV Q3W
SorafenibDRUGStandard dosing of Sorafenib
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Age ≥18 years * Histologically-confirmed advanced HCC with at least 1 target lesion measurable by modified RECIST. * Child-Pugh score A5 or A6. * ECOG Performance Status of ≤2. Exclusion Criteria: * Known central nervous system or brain metastases. * Prior anti-IGF-1R therap...

Countries:United StatesSingaporeTaiwanUnited Kingdom
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Frequently asked questions about BIIB022

What is BIIB022 used for?

BIIB022 is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer, Hepatocellular Carcinoma, and Solid Tumors. It is in Phase 1 clinical development and is not yet approved by the FDA.

What does BIIB022 target?

BIIB022 is an anti-IGF-1R monoclonal antibody, meaning it targets the insulin-like growth factor 1 receptor (IGF-1R). By binding to this receptor, it is designed to interfere with signaling pathways that can promote tumor growth.

Who makes BIIB022?

BIIB022 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The drug is currently in Phase 1 clinical trials for oncology indications.

What phase is BIIB022 in?

BIIB022 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. All three clinical trials listed for BIIB022 are Phase 1 studies that have been completed.

What clinical trials is BIIB022 in?

BIIB022 has been studied in three completed Phase 1 trials: NCT00555724 in relapsed/refractory solid tumors, NCT00956436 in hepatocellular carcinoma combined with sorafenib, and NCT00970580 in non-small cell lung cancer combined with paclitaxel and carboplatin.

Is BIIB022 the same as an anti-IGF-1R antibody?

Yes, BIIB022 is an anti-IGF-1R monoclonal antibody. It is designed to target the insulin-like growth factor 1 receptor, which is implicated in tumor growth. This mechanism is being evaluated in Phase 1 trials for solid tumors, hepatocellular carcinoma, and non-small cell lung cancer.