A Microdose Study of TTX-MC138-NODAGA-Cu64 in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05908773|
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : June 18, 2023
This is an open-label, single-center, single-arm, phase 0, microdose study in subjects with advanced solid tumors and radiographically confirmed metastases.
The study will evaluate delivery of TTX-MC138-NODAGA-Cu64 radiographically and establish the PK and biodistribution of TTX-MC138-NODAGA-Cu64 as determined by PET-MRI. The study consists of 3 parts: a screening period, dosing period, and follow-up period. The estimated total duration of the study is approximately 46 days.
Approximately 12 subjects with advanced metastatic solid tumors will be enrolled at 1 single site.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: TTX-MC138-NODAGA-Cu64||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Single-Center, Phase 0, Microdose Study to Demonstrate Delivery of TTX-MC138-NODAGA-Cu64 to Radiographically Confirmed Metastases in Subjects With Advanced Solid Tumors|
|Estimated Study Start Date :||July 7, 2023|
|Estimated Primary Completion Date :||January 1, 2025|
|Estimated Study Completion Date :||January 1, 2025|
- Drug: TTX-MC138-NODAGA-Cu64
TTX-MC138-NODAGA-Cu64 solution was developed as a PET radiopharmaceutical to permit assessment of delivery of TMX-MC138 to metastatic lesions in subjects with solid tumors. Subjects will be administered a microdose of TTX-MC138-NODAGA-Cu64 injection administered intravenously followed by whole body PET imaging.
- Injected Dose [ Time Frame: Throughout study completion for 12 subjects, average 12 months ]Measure the percent injected dose per cubic centimeter (%ID/cc) tissue of TTX-MC138-NODAGA-Cu64 in radiographically confirmed metastatic lesions in subjects with advanced solid tumors using PET-MRI.
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): NCT05908773
|Contact: Susan Duggan, RN, MBAemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Andreas Varkaris, MD, PhD 617-726-2000|