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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06184035 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, experimental cancer therapy, biologic therapy disqualifies patients from 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 qualify