OncoMatch/Clinical Trials/NCT06184035
A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer
Is NCT06184035 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies [177Lu]Lu-SN201 for solid tumor.
Treatment: [177Lu]Lu-SN201 — The purpose of this first-in-human (FIH) study is to determine the maximum tolerated dose (MTD) and to characterize the safety, tolerability, PK, and dosimetry profile of \[177Lu\]Lu-SN201 in adult participants with advanced solid tumors who have no standard of care treatment options. \[177Lu\]Lu-SN201 is a radiolabeled, nanomedical investigational medicinal product (IMP) whose mechanism of delivery is based on the Enhanced Permeability and Retention (EPR) effect.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic standard therapy
has failed at least one prior systemic standard therapy, or for which standard therapy is not appropriate, or for which no standard therapy exists
Cannot have received: chemotherapy
Exception: within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Chemotherapy, experimental cancer therapy, biologic therapy, or immunotherapy within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Cannot have received: experimental cancer therapy
Exception: within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Chemotherapy, experimental cancer therapy, biologic therapy, or immunotherapy within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Cannot have received: biologic therapy
Exception: within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Chemotherapy, experimental cancer therapy, biologic therapy, or immunotherapy within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Cannot have received: immunotherapy
Exception: within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Chemotherapy, experimental cancer therapy, biologic therapy, or immunotherapy within 2 weeks (or 5 half-lives, whatever is shortest) before the start of the study IMP administration
Cannot have received: palliative radiotherapy
Exception: completed less than 2 weeks before the start of the study IMP administration will be allowed as long as no more than 10% of the participant's bone marrow was irradiated
Palliative radiotherapy completed less than 2 weeks before the start of the study IMP administration will be allowed as long as no more than 10% of the participant's bone marrow was irradiated
Cannot have received: high-dose chemotherapy needing hemopoietin-stem-cell-rescue
Previous high-dose chemotherapy needing hemopoietin-stem-cell-rescue
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (transfusions allowed); ANC ≥ 1500/mm3; Platelet count ≥ 100,000 mm3
Kidney function
Serum creatinine ≤ 1.5 x ULN and eGFR > 30 mL/min/1.73 m2
Liver function
Total bilirubin ≤ 2.5 x ULN (≤ 5 ULN with liver metastases); ALT and AST ≤ 5 x ULN
Cardiac function
No clinically significant cardiac disease (see exclusion criteria for details)
Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements... (see criteria 5); Cardiac exclusion criteria (see exclusion 2)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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 qualify