Imaging of Solid Gastrointestinal Tumors
Conditions
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.
Interventions
DRUG[68Ga]MLN6907
IV Administration of \[68Ga\]MLN6907 on Day 1
Sponsors
Millennium Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study: * Male or female patients 18 years or older. * Must be diagnosed with colorectal cancer (CRC) with liver metastasis and eligible and scheduled for resection of liver metastases as part of their standard of care treatment plan. The planned surgery must occur greater than 14 days after the day of imaging. * Patients must consent to provide the sponsor with tumor tissue samples from their resected liver metastases. * Easter Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Female patients who are post menopausal, surgically sterile, or agree to practice effective methods of contraception from the time of signing the informed consent form through 60 days after the dose of \[68Ga\]MLN6907 or agree to practice true abstinence. * Male patients who agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the dose of \[68Ga\]MLN6907 or agree to practice true abstinence. * Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. * Suitable venous access for the study-required, blood sampling (ie, including PK sampling) * Adequate hepatic function as defined in the protocol. * Adequate renal function as defined in the protocol. * Hemoglobin ≥ 9 g/dL. * Recovery from all adverse effects from prior antitumor therapy to at least Common Terminology Criteria for Adverse Events (CTCAE) (V4.03) Grade 1.
Exclusion criteria
Patients meeting any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements | 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 | Day 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Plasma [68Ga]MLN6907 and MLN6907 drug substance precursor PK parameters and quantification of GCC levels in liver metastases | Day 1 | PK parameters include single-dose maximum (peak) concentration (Cmax), single-dose time to reach maximum (peak) concentration (Tmax), terminal disposition half-life (t1/2), and area under the plasma concentration versus time curve (AUC). |
| 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 | — |
Countries
Mexico, United States
Outcome results
None listed