Solid TumorPhase 1/2TumoradNCT06184035
A Dose Escalation and Expansion Study of [177Lu]Lu-SN201 in Participants With Advanced Cancer
A Phase 1/2 study testing [177Lu]Lu-SN201 in people with Solid Tumor and Metastatic Cancer, run by Spago Nanomedical AB at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Metastatic Cancer, Unresectable Solid Tumor
- What is being tested?
- [177Lu]Lu-SN201
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesAustralia
- Study dates
- 6 Dec 2023to 31 Dec 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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).
Show all 21Show fewer
- 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.
- 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 had menses at any time in the preceding 24 consecutive months).
- 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 ovulation [oral, intravaginal, transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD] or intrauterine hormone-releasing system).
- 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.
Who cannot join
- 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.
Show all 23Show fewer
- 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.
- 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 in the study.
- 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, whichever is the shortest.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites, 2 recruiting
- Recruiting
Cancer Research South Adelaide
Adelaide, South Australia, 5000
Vineet Kwatra, MD
- Recruiting
St Vincent Hospital Melbourne
Melbourne, Victoria, 3065
Kim Taubman, MD
About this study
Official title: Ph I/IIa Escalation/Expansion FIH, Open, Multi Center, Single Arm Study Evaluating Safety, Dosimetry and Early Efficacy of 177Lu-SN201 in Progressive/Treatment-refractory, Locally Advanced, Unresectable Metastatic or Recurrent Solid Tumors
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.
Read the detailed description
Eligible participants will receive [177Lu]Lu-SN201 via slow intravenous infusion on Cycle 1 Day 1. Participants will initially receive one cycle of treatment and will progress to a 2nd and 3rd cycle of treatment, provided retreatment criteria are met before the start of each cycle. The dosing schedule visit frequency will be every 6 weeks (with an allowable window to delay each cycle by +3 weeks per retreatment criteria), each participant may receive up to 3 cycles, with the treatment duration up to 22 weeks. A total of 3 treatment cycles will be given unless the participant meets early discontinuation criteria. For Cycle 1, an overnight hospitalization for standard-of-care observation following Day 1 clinic assessments to Day 2 is mandatory for all participants receiving Cycle 1.
Whole-body planar imaging, and single photon emission computed tomography (SPECT)/computed tomography (CT) will be performed post-administration of [177Lu]Lu-SN201 to assess biodistribution and dosimetry. CT or magnetic resonance imaging (MRI) will be used to assess the response of the disease to treatment using Response Evaluation Criteria (RECIST v1.1).
The general procedures for participants in Phase I and Phase IIa are summarized below:
- Baseline values are defined as the last collected value prior to the start of infusion.
- Continual assessment of adverse events (AEs) and concomitant medication usage will be conducted.
- Whole-body planar on Day 1, Day 2, Day 4, and Day 8 and SPECT/CT on Day 2, Day 4 and Day 8 will be used for biodistribution and dosimetry evaluation of all participants. If dosimetry has been met by previous participants at each dose level, the DMC may partly or fully exclude the requirement for dosimetry procedures in remaining participants at this dose level.
- For participants that will continue to treatment Cycle 2 or 3, eligibility assessment and IMP procurement will take place within the coming 17 days.
- Conditions
- Solid Tumor, Metastatic Cancer, Unresectable Solid Tumor, Recurrent Solid Tumor, Locally Advanced Solid Tumor, Refractory Cancer
- Being tested
- [177Lu]Lu-SN201
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[177Lu]Lu-SN201Drug
Also called Tumorad
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [177Lu]Lu-SN201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 24 months
Secondary outcomes (5)
Phase I/IIa: Measure peak plasma [177Lu]Lu-SN201 activity concentration (Cmax)
Characterize the pharmacokinetic Peak plasma concentration (Cmax) of the [177Lu]Lu-SN201 activity concentration over time
Measured: 48 months
Phase I/IIa: Measure plasma half-life of the [177Lu]Lu-SN201 activity
Characterize the pharmacokinetic half-life of the [177Lu]Lu-SN201 activity concentration over time in plasma
Measured: 48 months
Phase I/IIa: Measure the area under the plasma concentration versus time curve (AUC) of [177Lu]Lu-SN201 activity
Characterize the pharmacokinetic area under the curve vs time curve of the [177Lu]Lu-SN201 activity concentration in plasma over time
Measured: 48 months
Phase I/IIa: Evaluation of clinical dosimetry
To evaluate clinical dosimetry with whole-body planar and SPECT/CT imaging modalities to asses percentage injected dose of activity concentration and distribution of [177Lu]Lu-SN201 in tumor and organs.
Measured: 48 months
Phase IIa: Evaluation of clinical benefit based on disease control rates (DCR)
To evaluate clinical benefit based disease control rates (DCR) according to RECIST v1.1;
- Overall Response Rate (ORR).
- Duration of response (DoR).
- Progression-free survival (PFS).
- Overall survival (OS).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start6 Dec 2023
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spago Nanomedical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Taubman, Principal investigator, St Vincent Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184035
- Sponsor's protocol ID
- Tumorad-01
- Acronym
- Tumorad
- Status last verified
- Nov 2025
- First submitted
- 6 Dec 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No