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CNF2024

Phase 1

Breast Cancer | Small molecule | Oncology |Biogen Inc.|Last Updated: Jun 8, 2012

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

CNF2024 · 2 trials · 3 indications

Phase 1 2
NCT00412412CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD StudyBreast Cancer
COMPLETED34 Analytics
NCT00345189Study of Oral CNF2024 (BIIB021) in Advanced Solid TumorsTumors
COMPLETED70 Analytics
PHASE1COMPLETED
CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study
Breast CancerUnlock trial analytics
PHASE1COMPLETED
Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors
TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical and laboratory safety assessments
30 days after discontinuation of CNF2024 or until drug-related toxicites have returned to less than Grade 1
To determine the maximum tolerated dose (MTD)
Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment.
To determine the safety profile
Study duration
pharmacokinetic profile
Dosing period
effect on pharmacodynamic biomarkers
Dosing period
antitumor activity
At screening and after every 2 courses
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTALPatients with HER2- Breast Cancer
BEXPERIMENTALPatients with HER2+ Breast Cancer
Dosing Schedule 1OTHERStarting dose of 25 mg, with dosing twice a week for 3 weeks out of a 4-week course (Schedule 1). Dosing for schedule 1 is currently closed.
Dosing Schedule 2OTHERStarting dose of 600 mg, with dosing twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).

Interventions

NameTypeDescription
CNF2024DRUGOral doses of CNF2024 as specified in the protocol.
CNF2024 + trastuzumabDRUGOral doses of CNF2024 as specified in the protocol Intravenous doses of trastuzumab as specified in the package insert.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria (Group A): * Age ≥18 years at the time of informed consent. * Male and female subjects with confirmed HER2 adenocarcinoma of the breast with advanced disease (advanced disease will be defined as metastatic disease or locally advanced disease that is surgically unresectable and co...

Countries:United StatesUnited Kingdom
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about CNF2024

What is CNF2024 used for?

CNF2024 is an investigational small molecule being studied for the treatment of breast cancer and tumors. It was evaluated in Phase 1 clinical trials for advanced solid tumors and breast cancer, including in combination with Herceptin for HER2-positive breast cancer.

Who makes CNF2024?

CNF2024 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is CNF2024 in?

CNF2024 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in advanced solid tumors and one in breast cancer. The drug is investigational and has not been approved by the FDA.

What clinical trials is CNF2024 in?

CNF2024 has been studied in two completed Phase 1 trials. NCT00345189 evaluated oral CNF2024 in 70 patients with advanced solid tumors or lymphoma. NCT00412412 studied CNF2024 in 34 breast cancer patients, including a HER2-negative arm and a HER2-positive arm with Herceptin.

Is CNF2024 the same as BIIB021?

Yes, CNF2024 is also known as BIIB021. Clinical trial records refer to the drug as both CNF2024 and BIIB021, such as in the studies NCT00345189 and NCT00412412.