NL-OMON56388招募中不适用
An open-label, multicentre, integrated Phase 1 & 2 study to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of Lutetium (177Lu) rhPSMA 10.1 injection in men with metastatic castrate resistant prostate cancer - BET-PSMA-121 - Lutetium in men with prostate cancer
Blue Earth Therapeutics Limited0 个研究点目标入组 14 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
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. Male subjects, 18 years of age or older.
- •2. Willing to provide signed and dated written informed consent form (ICF)
- •prior to any study-specific procedures.
- •3. Willing to comply with required lifestyle restrictions following
- •administration of the IMP per local regulations.
- •4. Histologically confirmed adenocarcinoma of the prostate.
- •5. Serum testosterone levels <50 ng/dL (1.73 nmol/L) after surgical or
- •continued chemical castration.
- •6. Meets respective cohort-specific inclusion criterion for Phase 2 only.
- •7. Presence of disease target or non-target lesions (per RECIST v1.1) on CT/MRI
- •and/or full body 99mTc bone scan performed within 28 days of screening.
- •8. Positive disease expression of PSMA as confirmed on 18F-rhPSMA-7.3 PET/CT
- •scan. Note, for phase 1 only, a LOCAMETZ® or a positive PSMA PET/CT scan which
- •has already been obtained within 4 weeks (28 days) prior to screening may be
- •used for subject selection in Phase 1
- •9. At least 28 days or 5 half-lives (whichever is longer) elapsed between last
- •anti-cancer treatment administration and the initiation of study treatment
- •(except for Luteinising Hormone-releasing Hormone or GnRH).
- •10. Resolution of all previous treatment-related toxicities to CTCAE version
- •5.0 grade of <=1 (except for chemotherapy-induced alopecia and grade 2
- •peripheral neuropathy or grade 2 urinary frequency which are allowed).
- •11. Prior major surgery must be at least 12 weeks prior to study entry.
- •12. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a
- •life expectancy >=6 months.
- •13. Adequate bone marrow reserve and organ function as demonstrated by blood
- •count, and serum biochemistry at baseline:
- •* Platelet count >= 150 × 109/L
- •* WBC count >= 3.0 × 109/L
- •* Neutrophil count of >= 1.5 × 109/L
- •* Haemoglobin >= 10 g/dL
- •* Estimated glomerular filtration rate (using Chronic Kidney Disease
- •Epidemiology
- •Collaboration Creatinine Equation [2009]) (Levey 2009) >=60 mL/min
- •* Total bilirubin <1.5× ULN (except if confirmed history of Gilbert's disease)
- •* Serum albumin >=30 g/L
- •* AST <2× the ULN
- •* ALT <2× the ULN
- •14. Male subjects must not father children or donate sperm during the study and
- •for at least 6 months after the last study treatment. In addition, they must
- •agree to use effective contraception for this same period to protect partners
- •from any exposure to the IMP. For males with partners who are of childbearing
- •potential, effective contraception is a combination of male condom with either
- •cap, diaphragm, or sponge with spermicide (double barrier methods). A man is
- •only considered to be infertile if he has had bilateral orchidectomy or
- •successful vasectomy with laboratory confirmed aspermia.
- •15. Cohort-specific inclusion criteria:
- •a) Phase 1 and Phase 2 mCRPC: Subjects who have experienced disease
- •progression on or after at least 1 NAAD (e.g. abiraterone, enzalutamide), and
- •at least 1 course (but no more than 2 courses) of taxane-based chemotherapy.
- •b) Phase 2 mCRPC: Subjects who have experienced disease progression on or after
- 另有 2 项未显示
排除标准
- •1. Known hypersensitivity to the therapeutic or diagnostic IMP or any of its
- •constituents.
- •2. Presence of PSMA-negative disease: PSMA-negative disease defined as any
- •large PSMA-negative lymph node >1 cm in the short axis and/or a PSMA-negative
- •bone metastasis which has a significant soft tissue component suggesting
- •ongoing disease activity and/or a PSMA-negative solid organ metastasis >1 cm in
- •the long axis. In addition, subjects with significant low PSMA-expressing
- •disease should be excluded.
- •3. Diffuse marrow infiltration of disease (*superscan* appearance on full body
- •99mTc bone scan). A superscan is defined as bone scintigraphy in which there is
- •excessive skeletal radioisotope uptake in relation to soft tissues along with
- •absent or faint activity in the genitourinary tract and soft tissues due to
- •diffuse bone/bone marrow metastases. Further details regarding this appearance
- •are provided in the Image Acquisition Guidelines.
- •4. Symptomatic spinal cord compression, or clinical or radiological findings
- •that are indicative of impending spinal cord compression.
- •5. Known history of haematological malignancy.
- •6. Known history of central nervous system (CNS) metastases.
- •7. Histological findings consistent with neuroendocrine phenotype of prostate
- •8. Known history of other solid malignancy that may reduce life expectancy
- •and/or may interfere with disease assessment.
- •9. Unresolved urinary tract obstruction defined as radiographic evidence of
- •hydronephrosis with or without ureteric stent/nephrostomy. Where the clinical
- •team judges that the subject*s hydronephrosis is not obstructing, and renal
- •function meets the inclusion criteria, the subject may undergo 99mTc
- •mercaptoacetyltriglycerine scanning during the screening period and if the
- •result is non-obstructed, the subject can be eligible for the study.
- •10. Any uncontrolled significant medical, psychiatric, or surgical condition or
- •laboratory finding that would pose a risk to subject safety or interfere with
- •study participation or interpretation of individual subject results. For
- •cardiac conditions, this includes, but is not limited to, New York Heart
- •Association class III or IV congestive heart failure, history of congenital
- •prolonged QT syndrome, and myocardial infarction diagnosed within 6 months
- •prior to enrolment.
- •11. Ongoing treatment with bisphosphonates for bone-targeted therapy.
- •12. Severe urinary incontinence that would preclude safe disposal of
- •radioactive urine.
- •13. Single kidney or renal transplant or any concomitant nephrotoxic therapy
- •that might put the subject at high risk of renal toxicity during the study in
- •the judgement of the investigator.
- •14. Clinically significant abnormalities on a single 12-lead electrocardiogram
- •(ECG) at screening.
- •15. Previously received external beam irradiation to a field that includes more
- •than 30% of the bone marrow or kidneys.
- •16. Sponsor employees or investigator site personnel directly affiliated with
- •this study, and their immediate families. Immediate family is defined as a
- •spouse, parent, child, or sibling, whether biological or legally adopted.
- •17. Previous treatment with any of the following: PSMA-targeted radionuclide
- •therapy, Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223,
- •hemi-body irradiation.
- 另有 1 项未显示
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