Actively Recruiting
Phase I/IIa Study Evaluating Safety, Dosimetry, and Early Efficacy of 177Lu-SN201 in Adults With Advanced, Treatment-Refractory Solid Tumors
Led by Spago Nanomedical AB · Updated on 2025-11-20
90
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the investigational drug [177Lu]Lu-SN201 in adults with advanced solid tumors that have no standard treatment options. This first-in-human study aims to find the maximum tolerated dose and to understand the safety, tolerability, pharmacokinetics, and dosimetry of [177Lu]Lu-SN201, a radiolabeled nanomedicine designed to target tumors through a special delivery mechanism called the Enhanced Permeability and Retention effect. Participants will receive [177Lu]Lu-SN201 through slow intravenous infusion, starting with one treatment cycle and potentially progressing to up to three cycles if retreatment criteria are met. Each cycle occurs every six weeks, with a possible delay of up to three weeks. The study involves dose escalation across up to five dose levels to identify the best tolerated dose, followed by an expansion phase to further assess safety and early effectiveness in various tumor types. The first treatment cycle requires an overnight hospital stay for observation. Throughout the study, participants will undergo imaging scans such as whole-body planar imaging, SPECT/CT, CT, or MRI to monitor how the drug distributes in the body and to assess tumor response. Researchers will regularly check for side effects and monitor laboratory tests for organ function. Participants may receive up to three treatment cycles over about 22 weeks, with safety and disease control rates tracked for up to 48 months. Ongoing assessments will include adverse events, drug levels in blood, and clinical benefits in different tumor groups.
CONDITIONS
Brief Title
A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older.
- Histologically or cytologically confirmed recurrent, locally advanced, or metastatic solid tumor with no standard therapy or failed at least one prior systemic treatment.
- ECOG performance status between 0 and 2.
- Life expectancy of at least 3 months.
- Adequate bone marrow, liver, and kidney function based on specific lab values within 28 days before treatment.
- Stable dose of anti-coagulation therapy without bleeding or clotting issues.
- Use of effective contraception for men and women of childbearing potential during and after treatment.
- Ability to understand and comply with study requirements.
- At least one lesion measurable by RECIST v1.1 criteria for Phase I and Phase IIa.
You will not qualify if you...
- Unstable systemic diseases including active infections or significant liver, kidney, or metabolic problems.
- Significant heart conditions such as heart failure requiring treatment, low heart pumping function, uncontrolled high blood pressure, serious arrhythmias, or recent heart attack.
- Known allergy to pegylated drugs or vaccines.
- Other active cancers within the past 2 years except certain treated types.
- Infections not responding to treatment or serious infections.
- Active HIV, hepatitis B or C requiring treatment unless stable and controlled.
- Recent chemotherapy, experimental therapy, or immunotherapy within 2 weeks before study drug.
- Recent major surgery, biopsy, or trauma within 4 weeks before treatment.
- Psychiatric or functional disorders preventing informed consent or study compliance.
- Participation in another investigational study or use of investigational agents within 2 weeks before study drug administration.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 22 weeks
Participants receive up to 3 cycles of [177Lu]Lu-SN201 via slow intravenous infusion every 6 weeks, with an allowable delay of up to 3 weeks per cycle based on retreatment criteria. The first cycle includes an overnight hospital stay for standard-of-care observation following infusion.
1 visit every 6 weeks for up to 3 cycles; overnight hospitalization required after Cycle 1 Day 1 infusion
Duration - Throughout the treatment period and as needed after treatment completion
Participants undergo imaging assessments including whole-body planar scans and SPECT/CT to evaluate biodistribution and dosimetry, as well as CT or MRI to assess disease response using RECIST criteria. Adverse events and medication use are continually monitored.
Multiple imaging visits on Days 1, 2, 4, and 8 of each cycle; additional assessments depending on treatment cycles
Trial Site Locations
Total: 2 locations
1
Cancer Research South Adelaide
Adelaide, South Australia, Australia, 5000
Actively Recruiting
2
St Vincent Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Actively Recruiting
Research Team
C
Chief Development Officer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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