SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors

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 perfo

Trial Details

NCT ID
NCT07812805
Phase
PHASE1
Sponsor
SK Life Science, Inc.
Status
RECRUITING
Cancer Type
Pancreatic Ductal Adenocarcinoma Pancreatic Cancer
Interventions
  • SKL35501
  • SKL35502
Locations (sample)
  • Glen Burnie, Maryland, United States|39.16261,-76.62469
  • Pittsburgh, Pennsylvania, United States|40.44062,-79.99589
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784
  • Seoul, South Korea|37.566,126.9784

Key Eligibility Criteria

  • Participants are eligible to be included in the study only if all the following criteria apply:
  • Signed ICF.
  • Participants should be ≥ 18 years (in the US) or ≥19 years (in South Korea) of age at the time of signing the ICF.
  • Histologically and/or cytologically confirmed diagnosis of selected advanced or metastatic solid tumors (relapsed/refractory disease).

For full eligibility, visit ClinicalTrials.gov.

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