A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer

NCT06184035 | Recruiting Phase 1 DMC

• 1 other identifier: Tumorad-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumor; Metastatic Cancer; Unresectable Solid Tumor; Recurrent Solid Tumor; Locally Advanced Solid Tumor; Refractory Cancer

Outcome Measures

Primary Outcomes (4)

• Phase I/IIa: Frequency and severity of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

  Clinically significant safety laboratory results will be graded by NCI CTCAE v5.0. AEs (including physical examination, vital signs, ECG, and safety lab findings), related AEs, DLTs, SAEs, and related SAEs, AEs with NCI CTCAE Grades ≥ 3, AEs leading to premature discontinuation, interruptions, duration of interruptions and discontinuation of IRP will be analyzed descriptively utilizing corresponding Medical Dictionary for Regulatory Activities System Organ Classes and Preferred Terms. NCI CTCAE v5.0 toxicity grades will be utilized for classifying severity. Continual assessment of adverse events (AEs) and concomitant medication usage will be conducted.

  48 months

• Phase I/IIa: Incidence of Dose-Limiting Toxicity (DLT) during the first cycle of treatment.

  DLTs are defined as: * Any Grade ≥ 3 AEs of any etiology that are clinically significant and last \> 7 days except: * Nausea, vomiting, or diarrhea will be considered a DLT only if it persists at Grade ≥ 3 for \> 3 days despite adequate supportive care measures. At the Investigator's discretion, participants who experience nausea, vomiting, or diarrhea after receiving IMP may receive antiemetic or anti-diarrheal medication before subsequent doses of IMP. * Isolated laboratory abnormalities Grade ≥ 3 (not present at Baseline) that are not considered to be significant by the Investigator and are resolved to at least Grade 1 within 7 days without clinical sequelae or need for therapeutic intervention. * Any other toxicity occurring at any time during the study that in the view of the participating Investigators and the Medical Monitor represents a clinically significant hazard to the participant. DLTs will be confirmed by the DMC.

  48 months

• Phase I: Dose escalation to identify RP2D and/or MTD dose

  RP2D and/or MTD will be based on the DLT rate. Dose escalation will follow BOIN design, directed by the DLT rate (the current number of participants with DLT divided by the current number of participants in the cohort). The study will evaluate up to 5 dose levels of \[177Lu\]Lu-SN201, however additional dose levels may be explored until MTD/RP2D is identified. If the starting dose is not tolerated, a lower dose may be evaluated based on toxicity, safety, pharmacokinetics, and dosimetry data as determined by the DMC.

  24 months

• Phase IIa: Clinical benefit in solid tumor subgroups at RP2D and/or MTD

  Clinical benefit according to RECIST v1.1 of \[177Lu\]Lu-SN201, as defined by post-treatment tumor response and serum levels of applicable tumor markers, compared to baseline (last collected value/measurement before the start of treatment)

  24 months

Secondary Outcomes (5)

• Phase I/IIa: Measure peak plasma [177Lu]Lu-SN201 activity concentration (Cmax)

  48 months

• Phase I/IIa: Measure plasma half-life of the [177Lu]Lu-SN201 activity

  48 months

• Phase I/IIa: Measure the area under the plasma concentration versus time curve (AUC) of [177Lu]Lu-SN201 activity

  48 months

• Phase I/IIa: Evaluation of clinical dosimetry

  48 months

• Phase IIa: Evaluation of clinical benefit based on disease control rates (DCR)

  12 months

Other Outcomes (2)

• Phase I: Evaluation of clinical benefit based on disease control rates (DCR)

  12 months

• Phase I: Characterization of early signs of efficacy in tumor-type subgroups

  24 months

Study Arms (1)

Phase I/IIa Dose escalation and dose expansion

EXPERIMENTAL

Participants will initially receive 1 cycle of \[177Lu\]Lu-SN201 via slow intravenous infusion and progress to up to 3 cycles, provided retreatment criteria are met before the start of each cycle, occurring every 6 weeks (with an allowable window to delay each cycle by +3 weeks per retreatment criteria). Dose escalation: The study will evaluate up to 5 dose levels of \[177Lu\]Lu-SN201 (A1=10 MBq/kg, A2=25 MBq/kg, A=50 MBq/kg, A4= \<33% of A3, A5= \<33% of A4). Additional dose levels may be explored until MTD/RP2D is identified. Up to 9 participants may be enrolled at any pre-specified dose level shown to be tolerated for confirmation of MTD and/or RP2D. Dose expansion: Once the MTD/RP2D has been defined, an expansion phase consisting of multiple tumor types, each with up to 20 participants, will be enrolled to further characterize the safety, tolerability, and assess preliminary efficacy of \[177Lu\]Lu-SN201 at the RP2D and/or MTD identified in Phase I.

Drug: [177Lu]Lu-SN201

Interventions

[177Lu]Lu-SN201 DRUG

Intravenous infusion

Also known as: Tumorad

Phase I/IIa Dose escalation and dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants ≥ 18 years of age on the day of signing informed consent.
• Histologically or cytologically documented, recurrent, locally advanced, or metastatic solid malignancy that has failed at least one prior systemic standard therapy, or for which standard therapy is not appropriate, or for which no standard therapy exists.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Life expectancy ≥ 3 months.
• Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements, to be conducted within 28 days before the start of the study IMP administration:
• Hemoglobin ≥ 9.0 g/dL (transfusions are allowed).
• Absolute neutrophil count (ANC) ≥ 1500/mm3.
• Platelet count ≥ 100,000 mm3.
• Total bilirubin ≤ 2.5 x upper limit of normal (ULN) (in participants with liver metastases ≤ 5 ULN).
• Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 5 x ULN.
• On a stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and prothrombin/international normalized ratio and partial thromboplastin time (PT/INR and PTT, respectively) test results are compatible with the acceptable benefit-risk ratio at the Investigator's discretion.
• Serum creatinine ≤ 1.5 x ULN and estimated glomerular filtration rate (eGFR) \> 30 mL/min/1.73 m2 (per local values).
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Male participants must agree to use a highly effective method of birth control as defined in ICH M3(R2) starting with the first dose of study medication through 120 days after the last dose of study medication.
• Female participants of childbearing potential\* must have a negative pregnancy test documented at Screening and Baseline and be willing to use a highly effective method of contraception\*\* or practice abstinence starting from ICF signature through to 120 days after the last dose of study medication.

You may not qualify if:

• Unstable systemic disease (including but not limited to active infection, hepatic, renal, or metabolic disease).
• Clinically significant cardiac disease including any of the following:
• Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2).
• LVEF of \< 50%, as determined by MUGA or ECHO.
• Uncontrolled hypertension, defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy.
• History or presence of clinically significant ventricular arrhythmias or atrial fibrillation.
• Clinically significant resting bradycardia.
• Unstable angina pectoris ≤ 3 months before the start of study treatment.
• Acute myocardial infarction ≤ 3 months before the start of study treatment.
• Mean triplicate QT interval corrected for heart rate using Fridericia's formula (QTcF) value \> 480 msec (as specified in Section 10.5).
• Known hypersensitivity to pegylated drugs or vaccines (e.g., covid-19 vaccines).
• Concurrent or active solid or hematologic malignancy within the last 2 years with a distinct primary site or histology from the cancer being evaluated in this study except for the following cancer types: cervical cancer in situ, treated basal cell carcinoma, superficial bladder tumors (Ta and Tis).
• Infections not responding to therapy or active clinically serious infections.
• Known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV), or hepatitis C virus (HCV) infection requiring treatment. Participants with chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.
• NB: Participants with CNS metastases may be included after discussion with Sponsor, except for the sentinel participants.

Sponsors & Collaborators

• Spago Nanomedical AB: lead

Study Sites (2)

Cancer Research South Adelaide

Adelaide, South Australia, 5000, Australia

RECRUITING

St Vincent Hospital Melbourne

Melbourne, Victoria, 3065, Australia

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis; Neoplasms

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kim Taubman

  St Vincent Hospital Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chief Development Officer

CONTACT

+46 46 81188; info@spagonanomedical.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 28, 2023
• Study Start: December 6, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)