Phase 1 Study Of CEP-37250/KHK2804 In Subjects With Advanced Solid Tumors

Study Overview

Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors

This is a two-part, Phase 1 open label, multi-center, dose escalation study of CEP-37250/KHK2804 as monotherapy in subjects with advanced solid tumors who no longer respond to standard therapy or for whom no standard therapy is available.

The study will be conducted in two parts. In Part 1, a standard 3+3 designed dose escalation phase, subjects will receive CEP-37250/KHK2804, administered iv, once every week. A treatment cycle will consists of total of four doses per cycle. Part 2 of the study will enroll subjects with either colon cancer or pancreatic cancer to receive CEP-37250/KHK2804 at a dose to be determined following completion of Part 1. All subjects will receive study therapy until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the subject, or Investigator decision, up to a maximum of six cycles (approximately six months). After six cycles of CEP-37250/KHK2804 therapy, the subject may continue to receive CEP-37250/KHK2804 after discussion with the Sponsor and determination that the subject is experiencing a best response of at least stable disease (SD) and is not experiencing any unacceptable toxicities or dose limiting toxicities (DLTs).

Solid Tumour
Adenocarcinoma of the Colorectal
Adenocarcinoma of the Pancreas

DRUG: CEP-37250/KHK2804

CEP-37250/KHK2804-001

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-09-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-25
First Submitted that Met QC Criteria 2011-10-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-29
First Posted (ACTUAL) 2011-10-06	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part 1 Dose escalation in subjects with advanced solid tumors with Part 1 which includes intervention of CEP-37250/KHK2804	DRUG: CEP-37250/KHK2804 Part 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
EXPERIMENTAL: Part 2 Subjects with colorectal or pancreatic cancer Part 2 which includes intervention of CEP-37250/KHK2804	DRUG: CEP-37250/KHK2804 Part 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Part 1

Dose escalation in subjects with advanced solid tumors with Part 1 which includes intervention of CEP-37250/KHK2804

DRUG: CEP-37250/KHK2804

Part 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

EXPERIMENTAL: Part 2

Subjects with colorectal or pancreatic cancer Part 2 which includes intervention of CEP-37250/KHK2804

DRUG: CEP-37250/KHK2804

Part 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

Primary Outcome Measures	Measure Description	Time Frame
Adverse Event collection and assessment will be done for all 74 potentially treated subjects.	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.	at least 30 days or up to 12 weeks

Secondary Outcome Measures	Measure Description	Time Frame
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.	Participating subjects will have serial blood samples taken to determine the PK profile of study drug.	at least 30 days or up to 12 weeks
To screen for the development of antibodies against CEP-37250/KHK2804 (immunogenicity)	Subjects will have serial blood samples to check for the developments of anti-CEP-37250/KHK2804 antibodies.	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)).	Tumor measurements and disease response assessments will be performed on all participating subjects.	up to 30 days or up to 12 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 or recurrent, metastatic pancreatic adenocarcinoma and must have received at least one prior treatment regimen containing gemcitabine or 5-FU, and locally advanced primary or recurrent, metastatic colon adenocarcinoma.

Parts 1 and 2:

Have completed treatment for their brain metastasis > 4 weeks prior to scheduled study treatment start date;
Are neurologically stable;
Are on corticosteroids in doses no greater than physiological replacement (e.g., dexamethasone < 1.5 mg/day); and
Have a screening MRI scan of the brain that specifically verifies no evidence of CNS hemorrhage and no active gadolinium enhancing lesions;
Subjects with primary brain/CNS malignancy (e.g., gliomas, lymphomas) are excluded.

Hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins, or allergy to any component of the CEP-37250/KHK2804 finished drug and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, 5-HT3 antagonists, or corticosteroids.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Teva Pharma
Kyowa Hakko Kirin Pharma, Inc.

Investigators

STUDY_DIRECTOR: Michael Tirgan, MD, Kyowa Hakko Kirin Pharma, Inc.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Mita MM, Nemunaitis J, Grilley-Olson J, El-Rayes B, Bekaii-Saab T, Harvey RD, Marshall J, Zhang X, Strout V. Phase 1 Study of CEP-37250/KHK2804, a Tumor-specific Anti-glycoconjugate Monoclonal Antibody, in Patients with Advanced Solid Tumors. Target Oncol. 2016 Dec;11(6):807-814. doi: 10.1007/s11523-016-0449-2.

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Clinical Trial Record