64Cu-DOTA-pembrolizumab PET for the Study of PD1 Expression
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|ClinicalTrials.gov Identifier: NCT04605614|
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : August 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm||Radiation: Copper Cu 64-DOTA-pembrolizumab Biological: Pembrolizumab Procedure: Positron Emission Tomography||Phase 1|
I. To assess safety and tolerability of unlabeled pembrolizumab followed by 64Cu-tetraxetan (DOTA)-pembrolizumab positron emission tomography, at each dose level, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration.
I. Generate initial estimates of the biodistribution of the 64Cu-DOTA-pembrolizumab and the preferred dose of cold antibody.
II. Determine the dose of pre-administered unlabeled pembrolizumab that improves image quality by qualitative assessment by the radiologist of 64Cu-DOTA-pembrolizumab.
III. Evaluate the performance of 64Cu-DOTA-pembrolizumab in detecting tumor lesions.
OUTLINE: This is a dose-escalation study of 64Cu-DOTA-pembrolizumab.
Patients receive pembrolizumab intravenously (IV) over 30 minutes, and within 6 hours also receive 64Cu-DOTA-pembrolizumab via slow IV push over > 1 minute on day 0. Patients then undergo PET over 60 minutes on day 1.
After completion of study treatment, patients are followed up for 3 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of 64Cu Pembrolizumab PET Imaging for In Vivo Expression of PD1|
|Estimated Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||October 30, 2023|
|Estimated Study Completion Date :||October 30, 2023|
Experimental: Treatment (pembrolizumab, 64Cu-DOTA-pembrolizumab, PET)
Patients receive pembrolizumab IV over 30 minutes, and within 6 hours also receive 64Cu-DOTA-pembrolizumab via slow IV push over > 1 minute on day 0. Patients then undergo PET over 60 minutes on day 1.
Radiation: Copper Cu 64-DOTA-pembrolizumab
Procedure: Positron Emission Tomography
- Incidence of adverse events [ Time Frame: Up to 3 days ]Toxicity will be graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events version 5.0. Observed toxicities will be summarized, for all dose levels, in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study agent(s) and reversibility or outcome.
- Dose limiting toxicity [ Time Frame: During the first 3 days post the administration of radiolabeled pembrolizumab ]
- Detection of lesions in the body by 64Cu-DOTA-pembrolizumab positron emission tomography [ Time Frame: Up to 3 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04605614
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Ammar Chaudhry 626-218-6442 firstname.lastname@example.org|
|Principal Investigator: Ammar Chaudhry|
|Principal Investigator:||Ammar Chaudhry||City of Hope Medical Center|