OncoMatch/Clinical Trials/NCT07812805
SKL35501 With SKL35502 Imaging in Adults With NTSR1 Positive Advanced Solid Tumors
Official title: A Phase 1 Theranostic Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of SKL35501, an Alpha-Emitting Radiopharmaceutical Targeting NTSR1, With SKL35502 as Companion Imaging Agent in Adult Patients With Selected Advanced Solid Tumors
Is NCT07812805 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies SKL35501 for selected advanced solid tumors.
Treatment: SKL35501 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Tumor Agnostic
Colorectal Cancer
Pancreatic Cancer
Cholangiocarcinoma
Gastric Cancer
Biomarker criteria
Required: NTSR1 expression (uptake above background in at least 1 RECIST v1.1 measurable lesion on SKL35502 imaging)
Sufficient target (NTSR1) expression on SKL35502 imaging, defined as uptake above background in at least 1 RECIST v1.1 measurable lesion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
progressed following at least one prior line of therapy or for which no other standard therapy with proven clinical benefit is currently available or recommended
Cannot have received: radiopharmaceutical or radioligand therapy
Prior radiopharmaceutical or radioligand therapy
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (1500/μL), without G-CSF support; Platelet counts ≥ 100 × 10^9/L (100,000/μL) without thrombopoietin receptor agonists, other therapies for thrombocytopenia or platelet transfusion for ≥ 14 days prior to C1D1; Hemoglobin ≥ 90 g/L (9 g/dL), may be transfused or receive erythropoietic treatment to meet this criterion until > 14 days prior to C1D1; Albumin > 28 g/L
Kidney function
eGFR ≥ 60 mL/min (multiply the estimate of GFR by individual's BSA and divide by 1.73 m2)
Liver function
AST and ALT ≤ 3 × ULN (≤ 5 × ULN for patients with documented liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome)
Adequate hematologic and end-organ function, defined based on the following laboratory results obtained within (≤) 14 days prior to C1D1: ANC ≥ 1.5 × 10^9/L (1500/μL), without G-CSF support. Platelet counts ≥ 100 × 10^9/L (100,000/μL) without receiving any thrombopoietin receptor agonists, other therapies for thrombocytopenia or platelet transfusion for ≥ 14 days prior to C1D1. Hemoglobin ≥ 90 g/L (9 g/dL). Patients may be transfused or receive erythropoietic treatment to meet this criterion until (>) 14 days prior to C1D1. AST and ALT ≤ 3 × ULN (≤ 5 × ULN for patients with documented liver metastases). Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome). eGFR ≥ 60 mL/min (multiply the estimate of GFR by individual's BSA (calculated using an appropriate formula) and divide by 1.73 m2). Albumin > 28 g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- United Theranostics · Glen Burnie, Maryland
- UPMC Hillman Cancer Center · Pittsburgh, Pennsylvania
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07812805 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiopharmaceutical or radioligand therapy disqualifies patients from enrollment.
Does this trial require NTSR1?
Yes, NTSR1 expression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages