Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000185662
Ethics application status
Approved
Date submitted
30/01/2023
Date registered
22/02/2023
Date last updated
27/08/2024
Date data sharing statement initially provided
22/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Satoreotide Theranostic Pilot study in Extensive Stage in Small Cell Lung Cancer (ES-SCLC)
Scientific title
A multicentre, open-label, Phase I study investigating the safety, tolerability, and efficacy of 177Lu-SSO110 with 68Ga-SSO120 companion imaging in participants with extensive stage small cell lung cancer (ES-SCLC) who are on maintenance treatment with immune checkpoint inhibition (The LuSato1 Study).
Secondary ID [1] 308853 0
SSO110-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extensive Stage Small Cell Lung Cancer 328824 0
Condition category
Condition code
Cancer 325829 325829 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study involves the use of two investigational compounds in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC) receiving maintenance phase maintenance treatment with immune
checkpoint inhibition therapy (standard of care treatment for ES-SLSC).

The first is an investigational imaging product 68Ga-SSO120 (68Ga-Satoreotide Trizoxetan) which will be used for two screening scans that will be taken pre- and post- treatment dosing with 177Lu-SSO110. The first scan using 68Ga-SSO120 will be at least 18 days prior to the planned first 177Lu-SSO110 dose. The second 68Ga-SSO120 scan will be performed at the end of treatment visit, which will be in the 6th week post the last dose of 177Lu-SSO110. All study participants (approx. 70) will undergo the screening with 68Ga-SSO120 as per the study eligibility screening criteria.

68Ga-Satoreotide Trizoxetan is an imaging agent for patients with somatostatin receptor 2 (SSR2) positive tumours. 68Ga-SSO120 will be administered intravenously 40-90 minutes before the PET/CT scan which will last approximately 15-30 minutes. To ensure adherence to the intervention a schedule of clinic and hospital visits will be given to the patients which encompasses their standard of care as well as their clinical trial treatment plan. To monitor patient adherence to the intervention, all patient visits (missed or attended) will be tracked in the site’s electronic medical record (EMR). All participants will receive up to 2 single doses of 68Ga-SSO120 (1 at screening and the other at the end of treatment visit), with 68Ga radioactivity of 150 MBq injected intravenously. The administered radiation dose will be 150 +/- 50 MBq, and the peptide mass dose up to 50 µg (prepared from a vial containing 50 µg of SSO120) infused by slow intravenous push and flushed with 10 mL of normal saline (0.9% sodium chloride solution), as appropriate.

The second is an interventional radiopharmaceutical product 177Lu-SSO110 (177Lu-satoreotide tetraxetan) which is anticipated to be administered to approximately 30 of the 70 participants screened with 68Ga-SSO120. Four cycles of 177Lu-SSO110 therapy are planned per protocol each as a single intravenous infusion, with the first administered within 7 weeks of the last induction cycle of immune checkpoint inhibition therapy. The initial administered radiation dose of 177Lu-SSO110 will be 3.7 GBq with a potential dose escalation up to 5.2 GBq or de-escalation to 2.3 GBq.

Dose escalation and de-escalation is for the purpose of establishing a Recommended Phase 2 Dose (RP2D). In this study the dose will be determined by the Safety Review Committee (SRC) who will be closely monitoring all patients for the incidence of dose limiting toxicities (DLTs) to determine the maximum tolerated dose of 177Lu-SSO110. Prior to participant dosing the SRC will review the incidence of any DLTs and will follow the protocol dose escalation guide (following a Bayesian Optimal Interval/BOIN) design) to provide the most appropriate dosing decision.

Subsequent 177Lu-SSO110 administrations will be given 6 to 9 weeks after the preceding 177Lu-SSO110 administration. In the case of resolving toxicity, an extension of up to 12 weeks after the preceding 177Lu-SSO110 administration may be granted with subsequent 177Lu-SSO110 administration(s) also delayed accordingly. For participants with clinical benefit at the end of the 4 cycles the Investigator may request that the patient is provided with up to three additional treatments provided they meet all the criteria in in Section 9.6.5. of the protocol.

177Lu-SSO110 will be administered by intravenous infusion over up to 30 minutes using the hospital’s standard practice for peptide receptor radionuclide therapy - the preferred method for administration is the gravity method. Infusion rate can be modified (up or down) per the Investigator’s judgement and may be temporarily halted or further slowed down if the participant does not tolerate the infusion. The overall infusion duration should not exceed 60 minutes. Concomitant renal protection via amino acid infusion will be administered starting 30 minutes prior to 177Lu-SSO110 infusion and continuing for 4 hours as per the joint International Atomic Energy Agency (IAEA), European Association of Nuclear Medicine (EANM), and Society of Nuclear Medicine and Molecular Imaging (SNMMI) practical guidance on PRRT in NETs (Section 9.1.5 of the protocol). The duration and method of administration will be recorded in the case report form (CRF). All administration of treatment on the study will be conducted in a hospital setting and therefore adherence to their intervention schedule will be monitored in the clinic’s EMR.
Intervention code [1] 325300 0
Treatment: Drugs
Comparator / control treatment
There is no comparator group for this study. Approximately 70 participants will undergo screening with 68Ga-SSO120. It is anticipated that approximately 30 of the 70 screened patients may respond positively to the 68Ga-SSO120 scan and therefore demonstrate SST2 expression. These patients will enter then be eligible to enter the treatment period and will be administered 177Lu-SSO110 therapy. Participants who demonstrate non-responsiveness to the 68Ga-SSO120 scan will be considered screen failures. Furthermore patients who do not undergo 68Ga-SSO120 will also be screen failures and therefore will not act as comparators.

One of the main objectives for this phase I study is to determine the Recommended Phase II Dose (RP2D) and therefore a comparator will not be required to be utilised.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333841 0
Safety and tolerability of 177Lu-SSO110 as evaluated by:
• the incidence, properties, nature and severity of Drug-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
• abnormal laboratory parameters as assessed by safety blood tests
• vital signs (including body weight & height)
• ECG results
as reported and documented in the patient’s medical record and SAE reports.
Timepoint [1] 333841 0
AEs & SAEs will be assessed continuously from the time of consent until the completion of the end of treatment visit (or end of study if earlier than end of treatment), defined as the date of the last visit of the last participant in the study or two years after the last patient was enrolled, whichever occurs first. After the end of treatment visit, study drug related AEs will continue to be reviewed during long term follow up every 12 ± 4 weeks until withdrawal of consent, death, study completion, or study termination, whichever occurs earlier. Laboratory tests and vital signs will be assessed at every study visit from the first screening visit with 68Ga-SSO120 until the until the end of treatment visit (6 + 1 weeks post final dose of 177Lu-SSO110), and at other times if deemed necessary by the Investigator. 12–lead ECGs will be performed at the Screening Visit, pre-dose at standard of care ICI administration visits and at the end of treatment visit.
Primary outcome [2] 333842 0
Safety and tolerability of 68Ga-SSO120 as evaluated by:
• the incidence, properties, nature and severity of Drug-related Adverse Events (AEs) and Serious Adverse Events (SAEs)
• abnormal laboratory parameters as assessed by safety blood tests
• vital signs (including body weight & height)
• ECG results
as reported and documented in the patient’s medical record and SAE reports.
Timepoint [2] 333842 0
AEs & SAEs will be assessed continuously from the time of consent until the completion of the end of treatment visit (or end of study if earlier than end of treatment), defined as the date of the last visit of the last participant in the study or two years after the last patient was enrolled, whichever occurs first. After the end of treatment visit, study drug related AEs will continue to be reviewed during long term follow up every 12 ± 4 weeks until withdrawal of consent, death, study completion, or study termination, whichever occurs earlier. Laboratory tests and vital signs will be assessed at every study visit from the first screening visit with 68Ga-SSO120 until the until the end of treatment visit (6 + 1 weeks post final dose of 177Lu-SSO110), and at other times if deemed necessary by the Investigator. 12–lead ECGs will be performed at the Screening Visit, pre-dose at ICI administration visits and at the end of treatment visit.
Primary outcome [3] 333843 0
Incidence of dose limiting toxicities (DLTs) as evaluated by:
• blood samples and electrocardiogram (ECG) results
• incidence of AEs considered related to study drug(s) that occur during the observation period. E.g. Haematological AE (e.g. grade 4 neutropenia =7 consecutive days)
Timepoint [3] 333843 0
The DLT observation period is from the first dose of 177Lu-SSO110 until end of treatment visit, whether it is due to completion of administration or discontinuation of study drugs due to toxicity or confirmed disease progression.
Secondary outcome [1] 418451 0
Antitumour activity of 177Lu-SSO110 in participants on maintenance ICI therapy as assessed by Overall Survival (OS) Overall Survival (OS) as assessed by reports of: - participant death and Progression Free Survival (PFS), - Overall Response Rate (ORR), - Duration of Response (DoR) and - Disease Control Rate (DCR) as assessed by the Investigator using RECIST criteria v1.1.
Timepoint [1] 418451 0
Assessed continuously from first therapeutic intervention until either complete response, partial response, disease progression or death.
Secondary outcome [2] 418452 0
Percent concordance between lesions visible on 68Ga-SSO120 scan versus lesions visible on native contrast enhanced computed tomography (ceCT) and/or fluorodeoxyglucose (FDG) PET/CT on a lesion level (by participant and overall)
Timepoint [2] 418452 0
Assessed continuously from first therapeutic intervention until either complete response, partial response, disease progression or death.
Secondary outcome [3] 418453 0
Exploratory – predictive factors for toxicity following treatment with 177Lu-SSO110 as assessed by investigations that may include but are not limited to blood samples for anti-drug antibodies (ICI), tumour profiling (e.g. next-generation sequencing), activity kinetics of SSO110 assessed by dosimetry and lean body mass as calculated from CT scans.
Timepoint [3] 418453 0
Anti-ICI antibodies will be assessed on day 1 and at the end of treatment visit and End of Treatment Visit Tumour profiling if conducted as standard practice at the study site Activity kinetics assessed by dosimetry at each dosing visit of 177Lu-SSO110 Lean body mass will be assessed centrally, post-hoc from CT images obtained at screening and the end of treatment visits
Secondary outcome [4] 418454 0
Exploratory – predictive factors for efficacy
Timepoint [4] 418454 0
Anti-ICI antibodies will be assessed on day 1 and at the end of treatment visit and End of Treatment Visit Tumour profiling if conducted as standard practice at the study site Activity kinetics assessed by dosimetry at each dosing visit of 177Lu-SSO110
Secondary outcome [5] 418455 0
Exploratory – anti-tumour activity of 177Lu-SSO110 compared with historical controls of study derived endpoints of tumour activity (Overall Survival, Progression Free Survival, Overall Response Rate and Duration of Response), and historical controls available from trials of ICIs used with platinum based therapies and etoposide.
Timepoint [5] 418455 0
Assessed at the end of study using study derived endpoints
Secondary outcome [6] 418456 0
Exploratory – tumour response over time as assessed by comparison of study derived endpoints of tumour activity and historical controls available from trials of ICIs used with platinum based therapies and etoposide. Also assessed using study related CT, MRI, SPECT and PET scans.
Timepoint [6] 418456 0
Assessed during data analysis following the end of the study, defined as the date of the last visit of the last participant in the study or two years after the last patient was enrolled, whichever occurs first.

Eligibility
Key inclusion criteria
1. Aged at least 18 years (inclusive at the time of informed consent).
2. Must be able and willing to provide written informed consent prior to start of any study
procedures and assessments and must be willing to comply with all study procedures.
3. Confirmation of SCLC by histology or cytology. Confirmation of extensive stage SCLC
by imaging.
4. Adequate organ and marrow function within 7 days prior to the first dose of 177LuSSO110
as defined below:
a. absolute neutrophil count >1,000/µL;
b. platelets of >=100,000/µL;
c. total bilirubin >=1.5 × upper limit of normal (ULN) or >=3.0 × ULN for participants
with hereditary benign hyperbilirubinemia;
d. AST (aspartate aminotransferase or serum glutamic oxaloacetic transaminase,
SGOT) and ALT (alanine aminotransferase or serum glutamic pyruvic
transaminase, SGPT) <=3 × ULN (or <=5 × ULN if liver metastases are present);
e. serum creatinine <=1.5 × ULN;
f. estimated glomerular filtration rate >=45 mL/min/1.73 m2
;
g. serum albumin >=30 g/L.
5. Life expectancy of >18 weeks at confirmation of eligibility, in the opinion of the
Investigator.
6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic
gonadotropin test within 72 hours before the first dose of study drug and must not be
breastfeeding. WOCBP are defined as those who are not surgically sterile or
post-menopausal. Female participants will be considered post-menopausal if they have
been amenorrheic for 12 months without an alternative medical cause. Female participants
<50 years old who meet the criteria for post-menopausal status without previous surgical
sterilization should be considered for further investigation with luteinising hormone and
follicle stimulating hormone levels to confirm serological post-menopausal status.
7. WOCBP must agree to use a highly effective method of contraception during the study and for 90 days after the last dose of study drug.
8. Male participants who are able to father a child must agree to avoid impregnating a partner
and to adhere to a highly effective method of contraception during the study and for 90 days
after the last dose of study drug. All male participants must agree to not donate sperm
during the study and for 90 days after the last dose of study drug.
9. Positive 68Ga-SSO120 scan at screening is mandatory (positive being at least one lesion
concordant with a known lesion based on CT or FDGPET/CT with uptake visually assessed
as greater than the liver on 68Ga-SSO120 scan). In case there are no visible lesions on CT
(complete response) or a 68Ga-SSO120 scan cannot be performed due to technical reasons,
a positive test for SST2 from archival tissue or cytology (e.g., Fine Needle Aspiration
(FNA)) (positive being a H-score >50) is required.
10. To receive the first dose of 177Lu-SSO110, participants must have completed induction
therapy with cisplatin/carboplatin, etoposide and ICI, and be eligible for maintenance
therapy with an ICI.
11. Participants with brain metastases are eligible to participate if:
a. they are clinically and radiologically stable disease (no evidence of progression
by imaging; same imaging modality [magnetic resonance imaging or CT scan])
must be used for each assessment) for at least 28 days prior to the first dose of
study drug;
b. any neurologic symptoms returned to baseline;
c. no longer on steroids.
Note: Participants with a history of leptomeningeal disease may not participate even if
stable clinically.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
8.2. Exclusion Criteria
A participant who meets any of the following exclusion criteria must be excluded from the study:
1. Any previous radioligand therapy (e.g., peptide receptor radionuclide therapy).
2. Any concurrent malignancy. Patients with a malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this study at the Investigator’s discretion.
3. Any condition that precludes the adequate performance of PET and/or CT scan.
4. History of clinically significant allergic reactions attributed to compounds of similar
chemical composition to 68Ga, 177Lu, SSO110, SSO120, ICI, somatostatin analogue
peptides or other agents used in the study.
5. Any Grade >3 immune-related adverse event (irAE) during prior or current therapy with
any immunotherapy agent(s). Previous irAEs thought not to increase participant’s risk of
an investigational medicinal product-related AE, may be approved at the Investigator’s
discretion, if it is determined as unlikely to put the participant at an increased risk of
treatment-related toxicity and/or impact the integrity of study outcome (e.g.,
hypothyroidism on stable thyroxine replacement, adrenal insufficiency on stable hormone
replacement therapy, diabetes on stable insulin therapy).
6. Use of immunosuppressive medication >10 mg prednisolone per day or equivalent within
14 days prior to the first dose of 177Lu-SSO110.
Note: Use of immunosuppressive medications as prophylaxis in participants with contrast
allergies are acceptable. In addition, temporary uses of corticosteroids considered nonclinically relevant may be approved at the Investigator’s discretion.
7. Any unresolved AEs Grade >1 from prior anticancer therapy except for alopecia.
Participants with residual AEs Grade >1 considered unlikely to put the participant at an
increased risk of treatment-related toxicity and/or impact the integrity of study outcome
may be permitted on a case-by-case basis at the Investigator’s discretion (e.g., thyroid
disorders or cortisol insufficiency on stable hormone replacement therapy).
8. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s);
active bacterial, fungal, or viral infections requiring systemic therapy.
9. Live vaccine administration <=21 days prior to the first dose of study drug.
10. Active or previous autoimmune diseases, with the following exemptions:
a. Hashimoto’s thyroiditis on stable thyroid replacement therapy;
b. Type 1 diabetes mellitus on stable insulin therapy;
c. Other autoimmune disorders not considered to put participant at a higher risk of
irAE may be approved at the Investigator’s discretion.
11. History of primary immunodeficiency, bone marrow (BM) transplantation, or solid organ
transplantation.
12. History of inflammatory bowel disease, interstitial lung disease (pneumonitis), myocarditis,
Stevens-Johnson syndrome, or toxic epidermal necrolysis.
13. History of known alcohol or substance abuse and/or a known psychiatric illness/social
situation that would limit compliance with study requirements.
14. Has had or is scheduled to have major surgery <28 days prior to the first dose of study drug.
15. Known active human immunodeficiency virus or known active hepatitis B or C virus.
16. Known history within 4 months prior to first dose of study treatment or current
symptomatic heart failure as per New York Heart Association classes III-IV, unstable
angina, myocardial infarction, serious/uncontrolled/unstable cardiac arrhythmia, cerebral
vascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic
attack, or pulmonary embolism.
17. Known history of severe asthma and/or chronic obstructive airways disease requiring
systemic steroid therapy within 6 months prior to first dose of study treatment. Baseline
oxygen saturation reading at room air must be >90% by pulse oximetry.
18. Known history of severe eczema and other skin/pruritic conditions requiring systemic
steroid therapy within 6 months prior to first dose of study treatment.
19. Any extensive radiotherapy <=3 months before first 177Lu-SSO110 administration, defined
as external beam radiation (e.g., stereotactic ablative radiotherapy) to >25% of the BM or
brachytherapy.
20. A known superscan indicating extensive bony metastatic disease.
21. Received anticancer therapy (other than ICIs), including chemotherapy (except for ESSCLC induction chemotherapy), immunotherapy, biologic, herbal therapy, or any
investigational therapy or investigational device, within 18 days (or 5 half-lives for
biologic/non-cytotoxic agents, whichever is shorter), prior to the first dose of the study
drug.
22. High risk of bleeding due to uncontrolled coagulopathies or unstable vascular
malformations.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The use of historical controls referenced in Section 4: Outcomes refers to other clinical trials and specifically does not reference participants in this study. This study is a single group study design.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/03/2023
Actual
30/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 27007 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 27008 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 27009 0
GenesisCare - Murdoch - Murdoch
Recruitment hospital [4] 27010 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [5] 27011 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [6] 27012 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 27013 0
Liverpool Hospital - Liverpool
Recruitment hospital [8] 27014 0
Westmead Hospital - Westmead
Recruitment hospital [9] 27015 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 43081 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 43082 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 43083 0
6150 - Murdoch
Recruitment postcode(s) [4] 43084 0
3168 - Clayton
Recruitment postcode(s) [5] 43085 0
3165 - East Bentleigh
Recruitment postcode(s) [6] 43086 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 313076 0
Commercial sector/Industry
Name [1] 313076 0
Ariceum Therapeutics Australia Pty Ltd
Country [1] 313076 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ariceum Therapeutics Australia Pty Ltd
Address
58 Gipps Street, Collingwood, 3066 Victoria, Australia
Country
Australia
Secondary sponsor category [1] 314766 0
Commercial sector/Industry
Name [1] 314766 0
GenesisCare Clinical CRO Pty Ltd
Address [1] 314766 0
Building 7, Level 1, The Mill, 41-43 Bourke Road
Alexandria NSW 2015
Country [1] 314766 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312324 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 312324 0
Ethics committee country [1] 312324 0
Australia
Date submitted for ethics approval [1] 312324 0
14/12/2022
Approval date [1] 312324 0
09/02/2023
Ethics approval number [1] 312324 0
2022-12-1368
Ethics committee name [2] 316001 0
Monash Health Human Research Ethics Committee A
Ethics committee address [2] 316001 0
Ethics committee country [2] 316001 0
Australia
Date submitted for ethics approval [2] 316001 0
01/02/2023
Approval date [2] 316001 0
03/05/2023
Ethics approval number [2] 316001 0
Ethics committee name [3] 316002 0
Central Adelaide Local Health Network HREC
Ethics committee address [3] 316002 0
Ethics committee country [3] 316002 0
Australia
Date submitted for ethics approval [3] 316002 0
30/01/2024
Approval date [3] 316002 0
15/04/2024
Ethics approval number [3] 316002 0
2024/HRE00005

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124254 0
Prof Joe Cardaci
Address 124254 0
Diagnostic Nuclear Imaging, Hollywood Private Hospital, 101 Monash Avenue Nedlands 6009 WA
Country 124254 0
Australia
Phone 124254 0
+61412556901
Fax 124254 0
Email 124254 0
[email protected]
Contact person for public queries
Name 124255 0
Ben Wyse
Address 124255 0
GenesisCare Clinical CRO
Building 7, The Mill, 41-43 Bourke Road
Alexandria NSW 2015
Country 124255 0
Australia
Phone 124255 0
+61 491 819 717
Fax 124255 0
Email 124255 0
[email protected]
Contact person for scientific queries
Name 124256 0
Joe Cardaci
Address 124256 0
Diagnostic Nuclear Imaging, Hollywood Private Hospital, 101 Monash Avenue Nedlands 6009 WA
Country 124256 0
Australia
Phone 124256 0
+61 08 9366 1111
Fax 124256 0
Email 124256 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data will be publicly available. Data will be anonymised and analysed as a cohort.





What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18183Informed consent form  [email protected]



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