Clinical trialPhase 1Terminated
Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1
Phase 1 Study of 89Zr-DFO-HuMab-5B1 (MVT-2163) With HuMab-5B1 (MVT-5873) in Patients With Pancreatic Cancer or Other CA19-9 Positive Malignancies
- Outcome
- Stopped earlySponsor decision (Business decision)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- 11 July 2016
- Expected end
- 5 May 2017
- Enrollment
- 15 participants
- Sites
- 1
- Primary outcomes
- Safety of MVT-2163 alone and in combination with MVT-5873; Peak Plasma Concentration (Cmax) of MVT-2163 alone and in combination with MVT-5873; Biodistribution of MVT-2163 alone and in combination with MVT-5873; Dose of MVT-5873 required for optimal tumor visualization when combined with a fixed dose of MVT-2163; Determine the optimal time interval between MVT-2163 dose administration and tumor PET imaging
- Sponsor
- Industry
- Results posted
- No
- Last update
- 31 August 2021
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Brief summary public domain (ClinicalTrials.gov)
Open label, nonrandomized, dose-escalation trial of MVT-2163 and MVT-5873 used in performing PET scans. The study is designed to determine the best time and dose of these agents that result in the best PET image of a tumor. Subjects will be seen on days 1, 2, 4, and 7 for imaging and a clinical assessment. The last study visit is on day 28.
Detailed description public domain (ClinicalTrials.gov)
This is an open label, nonrandomized, dose-escalation trial of a fixed dose of MVT-2163 and varying antibody masses of MVT-5873. The study is designed to identify an optimal dose (total antibody mass) and optimal timing, for tumor imaging using PET scanning. This trial will include a dose escalation and an expansion phase. During the dose escalation portion of the study, a determination of the optimal time to perform PET imaging will be made. Following the identification of the "optimal" dose and timing, an 10 additional subjects will be imaged using the best dose and timing. In each portion of the study subjects will have a screening visit and, no more than 28 days later, those who are eligible for the study will receive MVT-2163. Each cohort will have 3-6 subjects. Subjects in cohort 1 will be administered MVT-2163 alone on day 1. Subjects in cohorts 2 and 3 will receive MVT-5873 on day 1, followed approximately 10 minutes later by MVT-2163. Subjects will return for visits to the clinic on days 2, 4, and 7 for additional imaging and safety assessments. A follow-up visit will occur on day 28. The study will also evaluate the tissue distribution and pharmacokinetics of MVT-2163 and, based on these data, the study will estimate the radiation dosimetry of MVT-2163. Safety assessments will be performed using ECGs, vital signs measurements, assessments of performance status, and clinical laboratory measurements.