NCT06504147招募中2 期
A Phase 2, Randomised, Open Label, Multicentre Study of an Intraperitoneal α-emitting Radionuclide Therapy (Radspherin®) in Patients With Primary Advanced High-grade Serous or High-grade Endometrioid Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, With Peritoneal Metastasis That Are Homologous Recombination Proficient and Scheduled to Undergo Neoadjuvant Chemotherapy and Interval Debulking Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 10
- 主要终点
- Progression free survival
研究概览
简要总结
This is a Phase 2, controlled, randomised, parallel assignment, open label, multicentre study to evaluate efficacy and safety of a single intraperitoneal injection of Radspherin® in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with peritoneal metastasis that are HR proficient and scheduled to undergo NACT and IDS. The study will be conducted in 2 parts; first, a Safety Lead-in Cohort will be recruited followed by the randomised part of the study. For both parts of the study, patients must be scheduled to undergo NACT and IDS and complete resection to no residual tumour (R0) should be deemed to be achievable during diagnostic work-up. Patients in both parts of the study will undergo the same procedures and assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide written informed consent and to comply with the clinical study protocol (CSP).
- •Female of age ≥ 18 years.
- •Patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (FIGO Stage IIIB/C or IV).
- •Peritoneal and other metastases eligible for IDS to no residual tumour.
- •Adverse events recovered to at least Grade 1 from the effects (excluding alopecia) of any prior medical therapy for malignancy.
- •Confirmed HR proficient tumour.
- •Received NACT (numbers of cycles as per investigator's discretion) with regress or stable disease on diagnostic imaging and assessed to be operable to R0 pre-surgery.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 to 2 and patient fit enough to undergo IDS and further treatment according to standard of care.
- •Adequate renal function:
- •Calculated creatinine clearance using the Cockcroft-Gault formula ≥ 40 ml/min or measured creatinine clearance ≥ 40 ml/min.
- •Adequate hepatic function:
- •Serum bilirubin < 1.5 x upper limit of normal (ULN), and
- •Aspartate transaminase and alanine transaminase ≤ 3 x ULN.
- •Adequate bone marrow function:
- •Absolute neutrophil count ≥ 1.0 x 10^9/l, and
- •Platelets ≥ 100 x 10^9/l, and
- •Haemoglobin ≥ 9 g/dL.
- •For females of childbearing potential, a negative pregnancy test must be documented prior to enrolment.
- •For females of childbearing potential agreement to use at least one of the following highly effective (failure rate < 1%) methods of contraception during the treatment period and for at least 9 months if they receive Radspherin®, unless hysterectomy or oophorectomy is performed during IDS.
- •Total abstinence (when this is in line with the preferred and usual lifestyle of the patient), periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception.
- •Female sterilisation (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least 6 weeks before enrolment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- •Use of oral (oestrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
- •Note: In addition to the use of one highly effective method of contraception as listed above, a condom is required for all male partners during the treatment period and for at least 9 months after the dose of IMP, unless vasectomised at least 6 months prior to enrolment.
排除标准
- •Known somatic or germline BRCA1 or BRCA2 mutations or confirmed HR deficient.
- •Suspicion of peritoneal leak, shunt, or otherwise suspected atypical target compartment pharmacokinetics, based on investigator's judgement, patient history and diagnostic images.
- •Epithelial borderline tumours, ovarian clear cell carcinoma, mucinous ovarian carcinoma, malignant Brenner tumours, non-epithelial ovarian malignancies, carcinosarcoma and neuroendocrine tumours or recurrent ovarian cancer.
- •Symptomatic central nervous system metastasis.
- •Another primary malignancy within the past 3 years (except for non melanoma skin cancer, cutaneous melanoma stage 1, cervical cancer in situ or FIGO 2023 Stage IA1 or IA3 prior or synchronous endometrial cancer).
- •Prior abdominal/pelvic radiotherapy.
- •Disease progression during NACT.
- •Pregnant or lactating (nursing) women.
- •Active infections requiring antibiotics, and/or physician monitoring, or recurrent fever > 38.0⁰C associated with a clinical diagnosis of active infection.
- •Active liver disease with positive serology for active hepatitis B, hepatitis C or known human immunodeficiency virus (HIV).
- •Concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/IV cardiac disease.
- •Any condition or illness that, in the opinion of the investigator or the medical monitor, would compromise the safety of the patients or interfere with the evaluation of the safety of the investigational medicinal product.
- •In the investigator's opinion not able to comply with study procedures. Any medical or psychological condition that would preclude participation in the study or compromise the ability to give informed consent.
- •Administration of an investigational medicinal product within 4 weeks, or at least 5 times the half life, prior to enrolment.
- •Concurrent administration of any cancer therapy other than planned study treatment within 4 weeks prior to, and up to 4 weeks after the surgery.
- •Treatment with bevacizumab within 5 weeks prior to IDS.
- •Known hypersensitivity to any of the excipients of the study drug.
研究组 & 干预措施
Radspherin
Experimental
干预措施: Radspherin (Drug)
Control
No Intervention
结局指标
主要结局
Progression free survival
时间窗: 24 months
To compare PFS in patients with primary advanced high-grade serous or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer1 with peritoneal metastasis that are HR proficient following Radspherin® treatment versus no treatment.
次要结局
- Peritoneal progression free survival(24 months)
研究者
研究点 (10)
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相关资讯
Oncoinvent Reaches 50% Recruitment Milestone in Phase 2 Ovarian Cancer Trial of Alpha-Emitting Radspherin- Oncoinvent has enrolled 54 of 108 planned patients in its Phase 2 trial of Radspherin for peritoneal metastases from ovarian cancer, reaching the 50% recruitment milestone.
- Year-to-date recruitment of 28 patients in 2026 has already surpassed total enrollment for all of 2025, reflecting strong acceleration across ten active trial sites.
- The randomized controlled trial compares progression-free survival between patients receiving a single intraperitoneal dose of Radspherin post-surgery plus chemotherapy versus standard of care alone.
- CEO Oystein Soug highlighted the encouraging safety profile and preliminary efficacy signals from earlier studies, noting limited treatment options for these patients following surgery.3 months agoOncoinvent Expands Phase 2 Trial Sites for Radspherin Radiopharmaceutical in Ovarian Cancer- Oncoinvent has activated four additional clinical sites for its Phase 2 trial of Radspherin® in patients with peritoneal carcinomatosis from ovarian cancer, with the first patient enrolled at a newly activated site.
- The randomized controlled trial is comparing progression-free survival between patients receiving Radspherin® after complete surgical resection following pre-operative chemotherapy versus patients receiving pre-operative chemotherapy and surgery alone.
- The study will recruit patients across 11 sites in six countries, with positive Phase 1/2a safety data showing Radspherin® was well tolerated with no dose-limiting toxicity at the recommended 7MBq dose.
- Radspherin® is an investigational radiopharmaceutical containing radium-224 alpha-emitting microparticles designed to target micro-metastases post-surgery in body cavities.7 months agoOncoinvent Completes Safety Lead-in Cohort Enrollment for Novel Alpha-radiation Therapy in Ovarian Cancer Trial- Oncoinvent has completed patient recruitment for the safety lead-in phase of its Phase 2 trial evaluating Radspherin®, a novel alpha-radiation therapy for peritoneal metastases from ovarian cancer.
- The trial will assess Radspherin® at a recommended dose of 7 MBq across multiple centers in the US, UK, EU, and Norway, marking a significant milestone in the drug's development program.
- The company expects to analyze and announce safety findings in March, followed by expansion into full trial enrollment for patients with peritoneal carcinomatosis.last yearOncoinvent's Radspherin Enters Phase 2 Trial for Ovarian Cancer Treatment- Oncoinvent has dosed the first patient in a Phase 2 clinical trial of Radspherin for peritoneal carcinomatosis originating from ovarian cancer.
- The randomized, controlled trial will evaluate Radspherin's efficacy and safety in improving progression-free survival post-surgery.
- Radspherin, an alpha-radiation therapy, delivers radium-224 directly to cancerous areas via calcium carbonate microparticles.
- The FDA previously granted Fast Track designation for Radspherin, expediting its development for peritoneal metastases from ovarian cancer.last year