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123-I-MIP-1072

Phase 1

Prostate Cancer | Small molecule | Oncology |Insight Molecular Diagnostics Inc.|Last Updated: Oct 12, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

123-I-MIP-1072 · 2 trials · 1 indication

Phase 1 2
NCT00992745A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate CancerProstate Cancer
COMPLETED24 Analytics
NCT00712829Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging AgentsProstate Cancer
COMPLETED12 Analytics
PHASE1COMPLETED
A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
Prostate CancerUnlock trial analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Pharmacokinetics, Tissue Distribution, Metabolism and Dosimetry of Two Prostate Cancer Imaging Agents
Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Estimate the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide in subjects with metastatic prostate cancer by determining the presence and extent of the disease.
24 hours post-injection
To examine the pharmacokinetics and organ radiation dosimetry of 123-I-MIP-1072 and 123I-MIP-1095 in patients with prior histological diagnosis of prostate cancer with evidence of recurrent metastatic disease.

Secondary Endpoints

Examine the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide on a per lesion basis in subjects with metastatic prostate cancer
Through 2 weeks post-injection
To describe the safety of administering 10.0 mCi and 5.0 mCi of 123I MIP 1072 for the detection of metastatic prostate cancer
Through 2 weeks post-injection
To examine whole body excretion and metabolism of 123-I-MIP-1072 and 123-I-MIP-1095 in patients with recurrent metastatic prostate cancer.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Previous ProstaScint®EXPERIMENTALSubjects with a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 alone.
No Previous ProstaScint®EXPERIMENTALSubjects without a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 and 111-In capromab pendetide imaging.
1EXPERIMENTAL123-I-MIP-1072 administration followed by 123-I-MIP-1095 administration two weeks later.
2EXPERIMENTAL123-I-MIP-1095 administration followed by 123-I-MIP-1072 administration two weeks later.

Interventions

NameTypeDescription
123-I-MIP-1072DRUGSingle 10 mCi intravenous injection
111-In capromab pendetideDRUGSingle 5 mCi intravenous injection
123-I-MIP-1095DRUG10 mCi intravenous injection given one time during the study
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites7

Subjects must meet all of the following criteria to be enrolled in this study. 1. Male aged 18 years or older 2. Signed written informed consent and willingness to comply with protocol requirements 3. Histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials

Frequently asked questions about 123-I-MIP-1072

What is 123-I-MIP-1072 used for in prostate cancer?

123-I-MIP-1072 is an investigational small molecule imaging agent being studied for use in prostate cancer. It is designed to help visualize prostate cancer, including metastatic disease, through imaging. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes 123-I-MIP-1072?

123-I-MIP-1072 is being developed by Insight Molecular Diagnostics Inc., a company listed under the ticker IMDX. The company is conducting clinical trials to evaluate the safety and imaging capabilities of this investigational agent in patients with prostate cancer.

What phase is 123-I-MIP-1072 in?

123-I-MIP-1072 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 36 participants enrolled. The drug remains investigational and has not received FDA approval for any indication.

What clinical trials is 123-I-MIP-1072 in?

123-I-MIP-1072 has been studied in two completed Phase 1 trials: NCT00712829, which evaluated safety, pharmacokinetics, and dosimetry in prostate cancer patients, and NCT00992745, a pilot study comparing 123I MIP 1072 to 111In capromab pendetide in metastatic prostate cancer. Both trials were conducted in the United States.

How does 123-I-MIP-1072 work?

123-I-MIP-1072 is a small molecule imaging agent designed to target prostate cancer cells. It is intended to bind to specific molecular targets associated with prostate cancer, allowing visualization of tumors through imaging techniques. The exact molecular target has not been disclosed in available information.