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临床试验/NL-OMON54819
NL-OMON54819招募中不适用

A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with advanced solid tumors known to overexpress gastrin-releasing peptide receptor (GRPR) - NeoRay

Advanced Accelerator Applications International SA0 个研究点目标入组 10 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10
研究概览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

入排标准

年龄范围
18 至 99（—）

入选标准

  • •1. Signed informed consent must be obtained prior to participation in the
  • •2. Adult patients (age >= 18 years old) with any of the following advanced or
  • •metastatic solid tumors:
  • •For Phase I: breast cancer, lung cancer, prostate cancer, GIST, GBM
  • •For Phase IIa:
  • •a. Cohort A: Breast cancer with histology as follows: HR- positive with ER >
  • •10% of nuclei stain, HER-2 negative and HER-2 low based on current practice and
  • •medical history.
  • •b. Cohort B: Prostate cancer
  • •c. Cohort C: GIST
  • •d. Cohort D: patients affected by any advanced/metastatic solid tumor type
  • •suspected to overexpress GRPR including recurrent GBM, and with moderate
  • •impaired renal function defined as creatinine clearance (calculated using the
  • •Cockcroft-Gault formula, or measured) >= 30mL/min and < 60mL/min.,
  • •3. At least one measurable lesion per RECIST 1.1 RANO (applicable for GBM only)
  • •criteria detected on the low-dose CT/MRI (for GBM MRI only) acquired together
  • •with the [68Ga]-NeoB PET. The same identified measurable lesion shows
  • •[68Ga]-NeoB uptake on PET/CT or PET/MRI. If the only matching lesion is located
  • •in the bone, the patient will still be eligible.,
  • •4. Patients for whom no standard therapy is available, tolerated or appropriate
  • •in both Phase I and Phase IIa. Specifically in the Phase IIa breast cancer
  • •cohort, patients need to have completed at least one prior treatment of
  • •endocrine therapy (including CDk4/6i) and at least one prior chemotherapy
  • •(unless contraindicated) in the metastatic setting. Patients with prior
  • •treatment with trastuzumab deruxtecan, alpelisib or elascestrant are also
  • •eligible. In case of confirmed presence of deleterious or suspected deleterious
  • •germline BRCA1 or BRCA2 mutation, the patient must also have already received a
  • •PARP inhibitor based therapy.
  • •5. Patient Eastern Cooperative Oncology Group (ECOG) performance status:
  • •For phase I: <= 2
  • •For phase IIa: <= 1

排除标准

  • •1. Patients who have not had resolution, except where otherwise stated in the
  • •inclusion/ exclusion criteria, of all clinically significant toxic effects of
  • •prior systemic cancer therapy, surgery, or radiotherapy to Grade <=1 (except for
  • •2. Creatinine clearance (calculated using Cockcroft-Gault formula, or measured):
  • •a. < 60 mL/min or serum creatinine >1.5 x ULN* for Phase I and Phase IIa
  • •(Cohort A, B and C)
  • •b. <30 mL/min and >= 60 mL/min for Phase IIa (Cohort D)
  • •3. Platelet count of < 75 x 10^9/L*.
  • •4. Absolute neutrophil count (ANC) < 1.0 x 10^9/L*.
  • •5. Hemoglobin < 9 g/dL*.
  • •6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x
  • •upper limit of normal (ULN) if no demonstrable liver metastases or > 5 x ULN in
  • •the presence of liver metastases*.
  • •7. Total bilirubin > 1.5 x ULN, except for patients with documented Gilbert*s
  • •syndrome who are eligible if total bilirubin <= 3 x ULN*.
  • •8. Serum amylase and/or lipase > 1.5 x ULN*.
  • •9. Known or expected hypersensitivity to [177Lu]-NeoB, [68Ga]-NeoB or any of
  • •their excipients.
  • •10. Impaired cardiac function or clinically significant cardiac disease,
  • •including any of the following:
  • •* Clinically significant and/or uncontrolled heart disease such as congestive
  • •heart failure requiring treatment (New York Heart Association (NHYA) grade >=
  • •2), uncontrolled arterial hypertension or clinically significant arrhythmia
  • •* LVEF < 50% as determined by echocardiogram (ECHO)*
  • •* QTcF >470 msec for females and QTcF >450 msec for males on screening
  • •electrocardiogram (ECG) or congenital long QT syndrome
  • •* Acute myocardial infarction or unstable angina pectoris < 3 months prior to
  • •[177LU]-NeoB (IMP1) administration.
  • •11. Patients with diabetes mellitus not stable under current treatment as
  • •judged by the investigator, or with hyperglycemia >= CTCAE version 5.0 grade 2*.
  • •12. Patients with history of or ongoing acute or chronic pancreatitis.
  • •13. Concurrent bladder outflow obstruction or unmanageable urinary incontinence.
  • •14. Administration of a radiopharmaceutical with therapeutic intent within a
  • •period corresponding to 10 half-lives of the radionuclide used prior to
  • •injection of [68Ga]-NeoB.
  • •15. Prior External Beam Radiation Therapy (EBRT) to more than 25% of the bone
  • •16. [223Ra]-therapy within the context of diffuse bone or bone marrow
  • •involvement (i.e. superscan defined as bone scintigraphy in which there is
  • •excessive skeletal radioisotope uptake [>20 bone lesions] in relation to soft
  • •tissues along with absent or faint activity in the genitourinary tract due to
  • •diffuse bone/bone marrow metastases).
  • •18. Patients who have received prior systemic anti-cancer treatment within the
  • •following time frames:
  • •* Cyclical chemotherapy within a period that is shorter than the cycle length
  • •used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-C) prior to
  • •starting [177Lu]-NeoB treatment
  • •* Biologic therapy (e.g. antibodies), continuous or intermittent small molecule
  • •therapeutics, or any other investigational agents within a period which is <= 5
  • •T1/2 or <= 14 days (whichever is shorter) prior to starting [177Lu]-NeoB
  • •19. History of somatic or psychiatric disease/condition that may interfere with
  • 另有 2 项未显示

研究者

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