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CEP-37250/KHK2804

Phase 1

Solid Tumour | Small molecule | Oncology |Teva Pharmaceutical Industries Limited|Last Updated: Apr 29, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

CEP-37250/KHK2804 · 1 trial · 3 indications

Phase 1 1
NCT01447732Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid TumorsSolid Tumour
COMPLETED71 Analytics
PHASE1COMPLETED
Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors
Solid TumourUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Event collection and assessment will be done for all 74 potentially treated subjects.
at least 30 days or up to 12 weeks

The safety of CEP-37250/KHK2804 will be determined by reported adverse events (AEs), changes in the physical examinations, vital laboratory evaluations, and treatment discontinuations due to toxicity.

Secondary Endpoints

To assess PK parameters which include: area under the plasma concentration versus time curve (AUC), peak plasma concentration (Cmax), t 1/2 and CL of CEP-37250/KHK2804.
at least 30 days or up to 12 weeks
To screen for the development of antibodies against CEP-37250/KHK2804 (immunogenicity)
at least 30 days or up to 12 weeks
To evaluate preliminary efficacy (overall response (Objective response rate(ORR; Complete Response(CR)+Partial Response(PR) and clinical benefit rate(CR+PR+stable disease(SD)).
up to 30 days or up to 12 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1EXPERIMENTALDose escalation in subjects with advanced solid tumors with Part 1 which includes intervention of CEP-37250/KHK2804
Part 2EXPERIMENTALSubjects with colorectal or pancreatic cancer Part 2 which includes intervention of CEP-37250/KHK2804

Interventions

NameTypeDescription
CEP-37250/KHK2804DRUGPart 1 is based on the CEP-37250/KHK2804 tolerability and safety data from three subjects enrolled in a cohort, enrollment at the next dose level or additional subjects into the ongoing cohort will occur based upon the number subjects with DLT at a given dose level. Dose depends on subject's body weight. Part 1 includes intervention of CEP-37250/KHK2804. Part 2 will receive CEP-37250/KHK2804 at a dose to be determined following completion of Part 1.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Adequate hepatic, renal, and hematologic function; * Life expectancy \> 3 months; * Part 1 and 2: The subject has histopathologically or cytologically documented, measurable, unresectable, locally advanced primary or recurrent, metastatic solid tumor, locally advanced primary ...

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Frequently asked questions about CEP-37250/KHK2804

What is CEP-37250/KHK2804 used for?

CEP-37250/KHK2804 is an investigational small molecule being developed for the treatment of solid tumors, including adenocarcinoma of the colorectal and adenocarcinoma of the pancreas. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does CEP-37250/KHK2804 target?

CEP-37250/KHK2804 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied in oncology for the treatment of advanced solid tumors, including colorectal and pancreatic adenocarcinomas.

Who makes CEP-37250/KHK2804?

CEP-37250/KHK2804 is being developed by Teva Pharmaceutical Industries Limited, a company listed on the stock exchange under the ticker TEVA. The drug is currently in Phase 1 clinical development for solid tumors.

What phase is CEP-37250/KHK2804 in?

CEP-37250/KHK2804 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. A Phase 1 study has been completed, but the drug remains in early-stage clinical testing.

What clinical trials is CEP-37250/KHK2804 in?

CEP-37250/KHK2804 has been studied in one clinical trial, NCT01447732, titled 'Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors.' This trial enrolled 71 participants with solid tumors, colorectal adenocarcinoma, and pancreatic adenocarcinoma, and has been completed.

Is CEP-37250/KHK2804 the same as KHK2804?

Yes, CEP-37250/KHK2804 is also known as KHK2804. The drug is referred to by both names in clinical research, and the Phase 1 trial NCT01447732 uses the combined name CEP-37250/KHK2804 to identify the investigational agent.