Study of 124I-NM404 in Advanced Solid Malignancies

Study Overview
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Brief Summary
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The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.

Detailed Description
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124I-NM404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (PET) scans. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more accurately see and evaluate cancerous tumors. This agent has been safely studied in animals and a limited number of human patients with lung cancer. This study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.

Official Title
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A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies

Conditions
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Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer

Intervention / Treatment
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* Drug: 124I-NM404


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of advanced solid malignancy. Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer Disease must be at least 1cm in diameter Brain metastasis must be stable for at least one month. ECOG performance status 0-2 Anticipated survival less than 5 years, as per the treating physician Exclusion Criteria: Skin lesions only Chemotherapy or radiotherapy within 1 week Residual toxicities of grade 2 or greater from prior therapy Adequate organ function as per specified laboratory parameter Platelet count > or = to 75,000/uL

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Triple Negative Breast<br>124I-NM404 in triple negative breast cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Prostate<br>124I-NM404 in prostate cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Colorectal<br>124I-NM404 in colorectal cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Gastric<br>124I-NM404 in gastric cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Ovarian<br>124I-NM404 in ovarian cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Pancreatic<br>124I-NM404 in pancreatic cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Esophageal<br>124I-NM404 in esophageal cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Sarcoma<br>124I-NM404 in soft tissue sarcoma | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|
| Head & Neck<br>124I-NM404 in head and neck cancer | Drug: 124I-NM404<br>* 124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal Imaging Parameters | To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head & neck cancer | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Number and grade of adverse events attributable to 124I-NM-404 | 2 years | 
| PET comparison | compare 18F-FDG PET to 124I-NM404 PET | 2 years |