Clinical trial NCT05547061: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
mCRPC
Keywords: PSMA
Lead sponsor: Cellbion Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 91
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Objective Response Rate(ORR) according to RECIST 1.1
timeFrame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
Secondary outcomes:
measure: PSA response rate(> 50% reduction compared to PSA before treatment)
timeFrame: baseline up to 24 weeks
measure: PSA % change
timeFrame: baseline up to 24 weeks
measure: PSA progression-free survival (PSA PFS)
timeFrame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
measure: Objective Response Rate(ORR) according to mPERCIST
timeFrame: baseline up to 24 weeks
measure: Best overall response(BOR) according to RECIST 1.1 and mPERCIST criteria
timeFrame: baseline up to 24 weeks
measure: Waterfall plot according to best PSA response
timeFrame: baseline up to 24 weeks
measure: Disease Control Rate(DCR) according to RECIST 1.1 and mPERCIST criteria
timeFrame: baseline up to 24 weeks
measure: Duration of Response(DOR) according to RECIST 1.1 and mPERCIST criteria
timeFrame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
measure: PSA Doubling time
timeFrame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
measure: Radiological progression-free survival (rPFS)
timeFrame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
measure: Waterfall plot according to tumor change rate
timeFrame: baseline up to 24 weeks
measure: Overall survival (OS)
timeFrame: From baseline until radiographic progression or death from any cause, whicheve. assessed up to 36 months.
measure: Pain intensity (NRS) and opioid analgesic use
timeFrame: baseline up to 24 weeks
measure: Quality of life (QOL): EORTC QLQ-C30, EORTC QLQ-PR25, EQ-5D-5L
timeFrame: baseline up to 24 weeks
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References: