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
- Conditions
- Neoplasms
- Registration Number
- KCT0006160
- Lead Sponsor
- Cellbion
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 73
* Healthy Participants
1) Male over 19 years old
2) Participants do not have congenital or chronic diseases and have no pathological symptoms or findings as a result of medical examination
3) Participants will be determined to be suitable as subjects as a result of clinical pathology tests such as blood pathology tests, blood chemistry tests, and urinalysis performed at the screening visit
4) Patients who voluntarily agreed to participate in this clinical trial and signed consent form
* Prostate cancer patients
1) Male patients over 19 years of age
2) Patients must have adenocarcinoma confirmed by histopathology or cytology.
3) Blood testosterone level meets the castration criterion (<50 ng/dL).
4) Patients with advanced metastatic castration-resistant prostate cancer who have failed the standard of care, and satisfy the following criteria:
-Previous treatment history for mCRPC: Patients who administered at least one of enzalutamide or abiraterone before/after docetaxel treatment.
-Patients who have confirmed disease progression before screening according to the Prostate Cancer Clinical Trials Working Group (PCWG) 3 standard in the state of internal/surgical castration during/after the previous treatment.
i.Soft-tissue disease progression: Soft tissue disease progression as defined by Solid Cancer Response Assessment Criteria Version 1.1 (RECIST v1.1).
ii. Bone disease progression: 2 or more new bone lesions
5) Patients must maintain androgenic deprivation therapy (ADT).
6) Patients must receive bone resorption treatment.
8) ECOG performance status = 2 patients
9) Patients must have an expected survival period of 6 months or longer
10) Patients must have adequate organ function :
-Absolute neutrophil count (ANC) = 1,500/µL (without G-CSF administration within 2 weeks prior to baseline)
-Platelet = 100,000/µL (without blood transfusion within 2 weeks prior to baseline)
-Hemoglobin = 9.0 g/dL (without blood transfusion within 4 weeks prior to baseline)
-Serum creatinine = 1.8 mg/dL or eGFR (or GFR) = 40 mL/min/1.73 m2
-Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 X ULN (however, AST and ALT = 5 X ULN in patients with confirmed liver metastasis)
-Total bilirubin = 1.5 X ULN (except for Gilbert syndrome)
-Prothrombin time (PT) and activated partial thromboplastin time (aPTT) = 1.5 X ULN
11) Patients who voluntarily agreed to participate in this clinical trial and signed consent form
* Healthy Participants
1) Participants with clinically significant acute or unstable disease
2) Participants have confirmed the following medical history or surgical history/operation history
-Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year prior to baseline
-Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection within 6 months prior to baseline
-Acute coronary syndrome within 6 months prior to baseline (unstable angina or myocardial infarction)
-Serious cerebrovascular disease such as stroke within 6 months prior to baseline
-General anesthesia within 4 weeks before baseline (2 weeks for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery) or major surgery requiring breathing aids
3) Participants with a history of severe drug hypersensitivity and hypersensitivity to drugs of a similar class to Investigational product.
4) Participants with severe claustrophobia that are not controlled by anti-anxiety drugs
5) Participants have hypersensitivity to the composition of the investigational product.
6) If the partner is a woman of childbearing potential, a person who does not intend to abstain for at least 3 months after the end of the clinical period and clinical investigational drug administration, or does not intend to use an appropriate contraceptive method
7) Participants who participated in a clinical trial within 6 months prior to baseline.
8) Participants are unable to participate in clinical trials when judged by other investigators
* Prostate cancer patients
1) Patients with hematologic malignancy including solid cancer and lymphoma other than prostate cancer within 3 years of baseline (however, appropriately treated non-melanoma skin cancer and superficial bladder cancer can be registered)
2) Patients who received chemotherapy, biotherapy, or immunotherapy for prostate cancer within 4 weeks of baseline (however, 6 weeks before baseline in the case of nitrosoureas or mitomycin)
3) Patients who received radiation chemotherapy or radiation therapy within 12 weeks of baseline
4) Patients who received high-dose chemotherapy requiring hematopoietic stem cell treatment within 2 years of baseline
5) Patients have received any PSMA targeted therapy previously(except DGUL), or who have received radiopharmaceutical treatment such as radium-223 within 6 months of baseline
6) Patients with symptomatic central nervous system metastasis
7) Patients have confirmed the following medical history or surgical history/operation history
-Deep vein thrombosis (DVT) or pulmonary embolism (PE) within 1 year prior to baseline
-Cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection within 6 months prior to baseline
-Acute coronary syndrome within 6 months prior to baseline (unstable angina or myocardial infarction)
-Serious cerebrovascular disease such as stroke within 6 months prior to baseline
-General anesthesia within 4 weeks before baseline (2 weeks for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery) or major surgery requiring breathing aids
8) Patients with the following diseases
-Class III or IV heart failure according to the New York Heart Association (NYHA) classification
-Uncontrolled hypertension (SBP> 160 mm Hg or DBP> 90 mm Hg)
-Clinically significant cardiovascular abnormalities by the investigator
-Uncontrolled cardiac arrhythmia
-Accompanying known HIV positive test or other uncontrolled
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate according to RECIST 1.1 criteria;adverse reactions, laboratory tests, vital signs, ECG etc.
- Secondary Outcome Measures
Name Time Method PSA response rate (>50% reduction compared to PSA before treatment);PSA % change;Best PSA response through waterfall plot;PSA progression-free survival (PSA PFS);Best overall response according to RECIST 1.1 and mPERCIST criteria;Radiological Progression Free Survival (rPFS);Waterfall plot according to tumor change rate(target lesion);Overall survival (OS);Pain intensity (NRS) and opioid analgesic use;Quality of Life (QOL): EORTC QLQ-C30, EORTC QLQ-PR25, EQ-5D-5L;Disease control rate according to RECIST 1.1 and mPERCIST criteria;Duration of Response according to RECIST 1.1 and mPERCIST criteria