89Zr-MMOT0530A PET Imaging in Patients With Unresectable Pancreatic or Platinum-resistant Ovarian Cancer Before Treatment With DMOT4039A. A Separate Study to the Phase I Study Protocol DMO4993g
A challenge in current drug development using molecular targeted therapies is the high level
of heterogeneity that is present in specific tumor types. The ability to safely and
accurately predict the presence or absence of the target is essential for the therapeutic
effect of the newly developed drugs. DMOT0439A is one of those novel designed molecular
targeted drugs; an antibody-drug conjugate composed of the monoclonal antibody MMOT0530A and
the mitotic agent monomethyl auristatin (MMAE). In the DMO4993g protocol (clinicaltrials.gov
identifier NCT01469793), the safety and efficacy of DMOT4039A is assessed in patients with
unresectable pancreatic or platinum-resistant ovarian cancer. By performing a 89Zr-MMOT0530A
PET scan prior to treatment with DMOT4039A, the uptake of the tracer in the primary and
metastatic tumor lesions can be evaluated. This is likely to provide important information
about target expression, whole body drug distribution and the correlation between tumor
uptake and response to therapy. Ultimately the use of a 89Zr- MMOT0530A PET as a
complimentary tool for patient selection and risk stratification can be evaluated. In part A
of this study, the optimal tracer dose of 89Zr- MMOT0530A and schedule for PET imaging will
be determined. In part B patients will have PET imaging before treatment in the DMO4993g
study on the dose and time points as assessed in part A.
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The in vivo biodistribution measured in SUV values and organ pharmacokinetics (PK) of 89Zr-MMOT0530A
The accumulation, distribution and localization of 89Zr-MMOT0530A in tumor tissue, organs and blood circulation, as assessed by PET. The quantitative uptake of 89Zr-MMOT0530A expressed in SUV (Standardized Uptake value).
Approximately 1 year
No
Elisabeth G. de Vries, MD PhD
Principal Investigator
University Medical Centre Groningen
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
MMOT imaging
NCT01832116
March 2013
May 2014
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