Completed

MMOT89Zr-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

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What is being tested

89Zr-MMOT0530A

Drug
Who is being recruted

Urogenital Diseases+16

+ Genital Diseases

+ Endocrine System Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 1
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity Medical Center Groningen
Last updated: May 3, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity Medical Center Groningen
Last updated: May 3, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

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

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleGonadal DisordersNeoplasmsNeoplasms by SiteUrogenital NeoplasmsFemale Urogenital DiseasesAdnexal DiseasesDigestive System DiseasesDigestive System NeoplasmsOvarian DiseasesOvarian NeoplasmsPancreatic DiseasesPancreatic Neoplasms

Criteria

5 inclusion criteria required to participate
Adequate hematological, renal and liver function

Adult patients, >= 18 years of age

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinum-resistant ovarian cancer

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5 exclusion criteria prevent from participating
Current Grade >= 2 toxicity (except for alopecia, anorexia and fatigue) from prior therapy or Grade >= 2 neuropathy

Known active infection

Pregnant or breastfeeding women

Treatment with anti-tumor therapy, including chemotherapy, biologic, experimental or hormonal therapy, within 4 weeks prior to Day 1

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

VU Medical Center

Amsterdam, NetherlandsOpen VU Medical Center in Google Maps

University Medical Center Groningen

Groningen, Netherlands
Completed2 Study Centers