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New treatment option for Solid Tumor
Official title A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer
ClinicalTrials.gov ID: NCT06184035
What this study is testing
What is [177Lu]Lu-SN201?
[177Lu]Lu-SN201 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as Tumorad.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy or bilateral oophorectomy, or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., had...
- Effective contraception is defined as contraceptive methods with a failure rate of \< 1% to prevent pregnancy (combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of...
- Written informed consent to study participation.
- Be able to understand and comply with the requirements of the study, as judged by the Investigator.
- Phase I: At least one lesion as per RECIST v1.1.
- Phase IIa: At least one measurable lesion as per RECIST v1.1.
What rules you out
- 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...
- 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...
- 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.
- 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.
- Not recovered to Grade 1 from any prior anti-cancer therapy, excluding alopecia.
- Previous high-dose chemotherapy needing hemopoietin-stem-cell-rescue.
- Major surgery, open biopsy, or significant trauma within 4 weeks before the start of study treatment.
- A psychiatric or functional disorder that prevents participants from providing informed consent or following protocol instructions.
- A participant that has a condition or is in a situation, in the Investigator's opinion may put the individual at significant risk, may confound the study results, or may interfere significantly with their participation...
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks or 5 half-lives of the agent...
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.