Company Update - MorphoSys

Carlumab (CNTO 888): CCL2 Specific
Antibody in Oncology
A Study of the Safety and Efficacy of CNTO 888 in
Combination With Standard of Care Chemotherapy in
Patients With Solid Tumors
Status Phase 1 (completed)
Study Design Non-randomized, open-label safety study
Study Start Date May 2010
Completion Date n.d.
Enrollment 53
Primary
Outcome
Measures
Secondary
Outcome
Measures
Treatment
Period
The primary objective of the study is to
evaluate the safety of CNTO 888 when
administered to patients with solid tumors in
combination with 4 standard of care
chemotherapy regimens (docetaxel;
gemcitabine; Paclitaxel and carboplatin; or
DOXIL®/ Caelyx® doxorubicin HCl liposome
injection)
� Pharmacokinetics [during study as specified in
the protocol and at End of Study (1 year)]
� Pharmacodynamics [during study as specified
in the protocol and at End of Study (1 year)]
Combination therapy will be continued until
disease progression, unacceptable toxicity, the
patient refuses further combination therapy,
withdraws consent, or is treated for 1 year
A Study of the Safety and Efficacy of Single-agent CNTO 888
(an Anti CC-Chemokine Ligand 2 [CCL2]) in Patients With
Metastatic Prostate Cancer
Status Phase 2 (completed)
Study Design Non-randomized, open-label safety/efficacy study
Study Start Date September 2009
Completion Date July 2011
Enrollment 46
Primary
Outcome
Measures
Secondary
Outcome
Measures
Treatment
Period
The primary objective of the study is to determine
the composite response in patients with
metastatic castrate-resistant prostate cancer
(CRPC) who receive single-agent 15 mg/kg
CNTO 888 every 2 weeks (Time Frame: 3-6
months)
� Objective response rate determined as complete
response and partial response according to
Response Evaluation Criteria in Solid Tumors
(RECIST) guidelines
� Progression Free Survival
� Overall Survival
15mg/kg intravenously every 2 weeks until
disease progression
© MorphoSys AG
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