SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This Phase 1, open-label study will evaluate two investigational radiopharmaceuticals in adults with selected advanced or metastatic solid tumors. SKL35502 is an imaging agent used with SPECT scans to identify tumors with neurotensin receptor 1 (NTSR1), a protein found on some cancer cells, and to assess where the agent travels in the body and the radiation dose delivered to tissues. Participants with sufficient SKL35502 tumor uptake may receive SKL35501, a treatment designed to deliver targeted alpha radiation to NTSR1-expressing tumor cells. Part A will evaluate the safety and imaging performance of SKL35502 and the safety, tolerability, pharmacokinetics, biodistribution, dosimetry, and biologically active dose range of SKL35501, as well as preliminary antitumor activity. Part B will further evaluate selected SKL35501 dose levels, including randomized low- and high-dose groups in participants with colorectal cancer, and will expand evaluation in selected tumor types. The study will also examine relationships among SKL35502 imaging, NTSR1 expression, SKL35501 tumor uptake, and treatment outcomes.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat (USA) lub 19 lat (Korea Południowa)
- •Potwierdzony zaawansowany nowotwór stały lub przerzuty raka
- •Nowotwór, który wrócił lub nie odpowiada na poprzednie leczenie
- •Wystarczająco duża ekspresja białka NTSR1 potwierdzona badaniem SKL35502
- •Co najmniej jedno zmieralne ognisko nowotworu widoczne w obrazie
- •Podpisana świadoma zgoda na udział w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (5)
United Theranostics
Glen Burnie, United States
UPMC Hillman Cancer Center
Pittsburgh, United States
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Trial contact
Ashley Villa
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/11/2026.
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