NCT02056015CompletedPhase 1
A Phase 1, First-in-Human, Single-Dose, Open-Label, Positron Emission Tomography (PET) Imaging Study of [68Ga]MLN6907 in Patients With Metastatic Colorectal Carcinoma.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 20
- Primary Endpoint
- Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements
Study Overview
Brief Summary
This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their treatment plan will be eligible for enrollment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
[68Ga]MLN6907
Experimental
Intervention: [68Ga]MLN6907 (Drug)
Outcomes
Primary Outcomes
Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements
Time Frame: Duration of study up to 26 months
Human organ and whole body absorbed dose values from organ kinetic quantification of [68Ga]MLN6907 uptake and clearance
Time Frame: Day 1
Secondary Outcomes
- Correlate tumor uptake of [68Ga]MLN6907 measured by PET and the level of guanylyl cyclase C (GCC) expression in tumor lesions from surgical specimens , for tumors in individual patients and for aggregated liver tumors across patients(Duration of study up to 26 months)
- Expert visual rating of [68Ga]MLN6907 liver tumor uptake and quantitative measurement of tumor-to-background (normal liver, muscle, etc.) ratio for each liver tumor(Duration of study up to 26 months)
- Time-activity curves for each liver tumor region of interest (ROI) and kinetic curves of the ratio of each liver tumor to background (including for normal liver, muscle, and blood); determination of the time for the maximum ratio for each tumor lesion(Duration of study up to 26 months)
- Plasma [68Ga]MLN6907 and MLN6907 drug substance precursor PK parameters and quantification of GCC levels in liver metastases(Day 1)
Investigators
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