A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Objective Response Rate(ORR) according to RECIST 1.1
研究概览
简要总结
This clinical trial is an open-label, single-arm, multi-center, escalation (Phase 1 Part B only), rater-blind (Phase 2 only), phase 1/2 trial to evaluate the diagnostic validity/safety of Ga-68-NGUL and efficacy/safety of Lu-177-DGUL on the anti-tumor activity that aims to simultaneously evaluate diagnostic and therapeutic validity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male patients of 19 years or older
- •Patients with metastatic diseases due to adenocarcinoma of the prostate as confirmed
- •Patients whose blood testosterone levels at the screening visit meet the castration criteria(< 50 ng/dL)
- •Patients with advanced metastatic castration-resistant prostate cancer who have failed standard treatment or no longer have standard treatment available
- •Those who are maintaining androgen deprivation therapy (ADT) regardless of the type
- •Patients receiving bone resorption treatment who have maintained a stable dose for at least 4 weeks prior to baseline
- •Patients with positive lesions on Ga-68-NGUL PET scan
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Patients with an expected survival of 6months or more
- •Patients with confirmed adequate hematological function, renal and hepatic function according to the following criteria
- •Patients who have voluntarily consented to participate in this clinical trial and signed the informed consent form
排除标准
- •Patients with hematologic malignancy, including lymphoma and solid cancers other than prostate cancer, within 3 years prior to baseline
- •Patients who have received chemotherapy, biotherapy, or immunotherapy for prostate cancer treatment within 4 weeks prior to baseline
- •Patients who have received radiation chemotherapy or radiation therapy within 12 weeks prior to baseline
- •Patients who have received high-dose chemotherapy requiring hematopoietic stem cell therapy within 2 years prior to baseline
- •Those who had previously received PSMA-targeted treatment or received radiopharmaceutical treatment, such as radium-223, within 6 months prior to baseline
- •Patients with symptomatic central nervous system metastases
- •Patients with unsuitable medical history or surgical/procedural history
- •Patients with severe drug hypersensitivity and a history of hypersensitivity to the investigational product and similar drugs
- •Patients receiving concomitant nephrotoxic drugs
- •Patients with severe claustrophobia that is not controlled with anti-anxiety medications
- •Patients with hypersensitivity reactions to components of the investigational product
- •If the partner is a female of childbearing potential, patients who do not intend to abstain from abstinence or use appropriate contraceptive methods for at least 3 months after the end of the clinical trial period and investigational product administration
- •Patients who have been administered with other investigational products or treated with clinical investigational devices within 4 weeks prior to baseline
- •Patients who cannot participate in the clinical trial as determined by other investigators
研究组 & 干预措施
Phase 1 Part A(Healthy/Disease group)
Subjects are administered intravenously a single dose of 2MBq/kg of Ga-68-NGUL.
干预措施: Ga-68-NGUL (Drug)
Phase 1 : Part B(Low dose)
Subjects with positive lesions for Ga-68-NGUL are administered intravenously with low dose(150mCi) of Lu-177-DGUL.
干预措施: Lu-177-DGUL (Drug)
Phase 1 : Part B(Low dose)
Subjects with positive lesions for Ga-68-NGUL are administered intravenously with low dose(150mCi) of Lu-177-DGUL.
干预措施: Ga-68-NGUL (Drug)
Phase 1 : Part B(High dose)
Subjects with positive lesions for Ga-68-NGUL are administered intravenously with high dose(200mCi) of Lu-177-DGUL.
干预措施: Lu-177-DGUL (Drug)
Phase 1 : Part B(High dose)
Subjects with positive lesions for Ga-68-NGUL are administered intravenously with high dose(200mCi) of Lu-177-DGUL.
干预措施: Ga-68-NGUL (Drug)
Phase 2
Subjects with positive lesions for Ga-68-NGUL are administered intravenously with Lu-177-DGUL with the determined RP2D.
干预措施: Lu-177-DGUL (Drug)
Phase 2
Subjects with positive lesions for Ga-68-NGUL are administered intravenously with Lu-177-DGUL with the determined RP2D.
干预措施: Ga-68-NGUL (Drug)
结局指标
主要结局
Objective Response Rate(ORR) according to RECIST 1.1
时间窗: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
ORR is defined as the proportion of participants with best overall response of complete response or partial response according to RECIST 1.1
次要结局
- PSA response rate(> 50% reduction compared to PSA before treatment)(baseline up to 24 weeks)
- PSA % change(baseline up to 24 weeks)
- PSA progression-free survival (PSA PFS)(From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months)
- Waterfall plot according to best PSA response(baseline up to 24 weeks)
- Objective Response Rate(ORR) according to mPERCIST(baseline up to 24 weeks)
- Best overall response(BOR) according to RECIST 1.1 and mPERCIST criteria(baseline up to 24 weeks)
- Disease Control Rate(DCR) according to RECIST 1.1 and mPERCIST criteria(baseline up to 24 weeks)
- Duration of Response(DOR) according to RECIST 1.1 and mPERCIST criteria(From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months)
- PSA Doubling time(From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months)
- Pain intensity (NRS) and opioid analgesic use(baseline up to 24 weeks)
- Quality of life (QOL): EORTC QLQ-C30, EORTC QLQ-PR25, EQ-5D-5L(baseline up to 24 weeks)
- Radiological progression-free survival (rPFS)(From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months)
- Waterfall plot according to tumor change rate(baseline up to 24 weeks)
- Overall survival (OS)(From baseline until radiographic progression or death from any cause, whicheve. assessed up to 36 months.)