Actively Recruiting
A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer
Led by Spago Nanomedical AB · Updated on 2025-11-20
90
Participants Needed
2
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 on the day of signing informed consent
- Histologically or cytologically confirmed recurrent, locally advanced, or metastatic solid tumor that has failed at least one prior standard therapy or has no appropriate standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
- Adequate bone marrow, liver, and kidney function based on recent laboratory tests within 28 days before treatment
- Stable on anti-coagulation therapy without bleeding or clotting issues and acceptable blood clotting test results
- Serum creatinine less than or equal to 1.5 times the upper limit of normal and estimated glomerular filtration rate above 30 mL/min/1.73 m2
- Use of contraception consistent with local regulations for men and women of childbearing potential during and up to 120 days after the last dose
- Written informed consent provided
- Ability to understand and comply with study requirements as judged by the Investigator
- Presence of at least one lesion measurable by RECIST v1.1 (Phase I and Phase IIa)
You will not qualify if you...
- Unstable systemic diseases such as active infections or serious liver, kidney, or metabolic problems
- Significant heart disease including heart failure requiring treatment, low left ventricular ejection fraction, uncontrolled high blood pressure, serious arrhythmias, bradycardia, recent unstable angina or heart attack, or prolonged QT interval
- Known allergy to pegylated drugs or vaccines
- Active or concurrent different cancers within last 2 years except certain treated skin or cervical cancers
- Serious infections not responding to treatment
- Known HIV infection or active hepatitis B or C requiring treatment, except stable chronic infection under control
- Recent chemotherapy, experimental therapy, biologic therapy, or immunotherapy within 2 weeks before study treatment
- Recent palliative radiotherapy within 2 weeks if more than 10% of bone marrow was irradiated
- Not recovered to mild or no side effects from prior cancer therapy except hair loss
- Previous high-dose chemotherapy requiring stem cell rescue
- Major surgery, biopsy, or trauma within 4 weeks before study treatment
- Psychiatric or functional disorders preventing informed consent or participation
- Any condition or situation posing significant risk or interfering with study participation as judged by Investigator
- Participation in another investigational drug or device study within 2 weeks or five half-lives of previous agent, whichever is shorter
AI-Screening
AI-Powered Screening
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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
CONTACT
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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