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

Part of paid clinical trials in Glen Burnie, Maryland.

Sponsor
SK Life Science, Inc.
Study ID
NCT07812805
Phase
PHASE1
Status
Recruiting
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Conditions

  • Biliary Tract Cancer (BTC)
  • Colorectal Cancer (CRC)
  • Esophageal Cancer (EC)
  • Gastric Cancer (GC)
  • Head and Neck Squamous Cell Cancer (HNSCC)
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Selected Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SKL35501 — DRUG
    Therapeutic agent that consists of an NTSR1-targeting small molecule linked to alpha emitter 225Ac to induce killing of NTSR1-expressing tumor cells
  • SKL35502 — DIAGNOSTIC_TEST
    Imaging agent that consists of an NTSR1-targeting small molecule linked to 111In to detect NTSR1-expressing tumors via SPECT imaging

Study Details

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.

Key Dates

First listed
Sep 10, 2026
Start date
Aug 19, 2026
Status verified
Sep 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SKL35501 Low Dose
    Description: For dose optimization, one cohort with 2 groups (Low Dose SKL35501 group and High Dose SKL35501 group) will be initiated in part B of the study
  • Experimental: SKL35501 High Dose
    Description: For dose optimization, one cohort with 2 groups (Low Dose SKL35501 group and High Dose SKL35501 group) will be initiated in part B of the study

Primary Outcome Measure

Number of Participants With Treatment-Emergent Adverse Events Following SKL35502 Administration [ Time Frame: From the first administration of SKL35502 until initiation of SKL35501, 15 days after the last administration of SKL35502, or initiation of a new antitumor therapy, whichever occurs first. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
United TheranosticsGlen BurnieMaryland21061
Taylor Weeks
[email protected]
677-467-3669
Babak Saboury, MD, MPH (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Alex Scheetz
[email protected]
412-623-2688
Neeta Pandit-Taskar (PRINCIPAL_INVESTIGATOR)

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By research site
United Theranostics· Glen Burnie, MDUPMC Hillman Cancer Center· Pittsburgh, PA

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