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Two-Part, Open-Label, Multi-Center Phase 1 Study of Monoclonal Antibody CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Solid Tumour, Adenocarcinoma of the Colorectal, Adenocarcinoma of the Pancreas

Thank you

Trial Information

Two-Part, Open-Label, Multi-Center Phase 1 Study of Monoclonal Antibody CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors

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).

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 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.

Exclusion Criteria:

- Parts 1 and 2:

1. Malignant melanoma, Merkel cell cancer, small cell lung cancer, lymphoepithelial
carcinoma, malignant mesothelioma, GIST, Hodgkin and NHL, thymoma,
neuroendocrine, neuronal tumors, and sarcomas. This list of excluded tumors may
be modified as additional research findings become available on target antigen

2. The subject has received anti-cancer chemotherapy, hormonal therapy,
radiotherapy, immunotherapy, or investigational agents within 4 weeks (6 weeks
for mitomycin C and nitrosoureas) prior to the first dose of CEP-37250/KHK2804;

3. The subject has received monoclonal antibodies of any type or for any form of
disease within 4 weeks of the first dose of CEP-37250/KHK2804;

4. Major surgery within 4 weeks prior to the first dose;

5. Known symptomatic brain metastases (screening magnetic resonance imaging (MRI)
of the brain is only required when there is clinical suspicion of central
nervous system [CNS] involvement or past history of treated brain metastasis).
Subjects with treated brain metastasis (radiotherapy and/or surgery) will be
eligible if they:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Event collection and assessment will be done for all 74 potentially treated subjects.

Outcome Description:

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.

Outcome Time Frame:

at least 30 days or up to 12 weeks

Safety Issue:


Principal Investigator

Bruce Silvers, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Pharma, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

October 2011

Completion Date:

January 2014

Related Keywords:

  • Solid Tumour
  • Adenocarcinoma of the Colorectal
  • Adenocarcinoma of the Pancreas
  • Monoclonal antibody (Mab)
  • Antibody dependent cellular cytotoxicity (ADCC)
  • Complement-dependent toxicity (CDC)
  • Non-fucosylated immunoglobulin G
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms



Cedars Sinai Medical CenterLos Angeles, California  90048-1804
The Ohio State UniversityColumbus, Ohio  43210
Emory UniversityAtlanta, Georgia  30322
Mary Crowley Cancer CenterDallas, Texas  75246
UNC - Chapel HillChapel Hill, North Carolina  27599