Satoreotide Theranostic Pilot study in Extensive Stage in Small Cell Lung Cancer (ES-SCLC)
- Conditions
- Extensive Stage Small Cell Lung CancerCancer - Lung - Small cell
- Registration Number
- ACTRN12623000185662
- Lead Sponsor
- Ariceum Therapeutics Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
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 m
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 he
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method