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临床试验/ACTRN12623000185662
ACTRN12623000185662招募中1 期

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).

Ariceum Therapeutics Australia Pty Ltd0 个研究点目标入组 70 人开始时间: 2023年2月22日最近更新:
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适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
70
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit（—）
性别
All

入选标准

  • •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

排除标准

  • •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

研究者

发起方
Ariceum Therapeutics Australia Pty Ltd

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