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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05547061
• Other study ID #: Lu-PSMA001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 12, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Cellbion Co., Ltd.
• Contact: Seungtae On, Pharm.D.
• Phone: 82-10-7373-9768
• Email: seungtae.on[@]cellbion.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 73
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• mCRPC
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Lu-177-DGUL
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.
• Ga-68-NGUL
Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Cellbion Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate(ORR) according to RECIST 1.1	ORR is defined as the proportion of participants with best overall response of complete response or partial response according to RECIST 1.1	From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
Secondary	PSA response rate(> 50% reduction compared to PSA before treatment)	defined as the proportion of subjects who achieved a PSA response, which is considered a reduction of > 50% from baseline prior to treatment	baseline up to 24 weeks
Secondary	PSA % change	defined as the % change of PSA level compared to baseline.	baseline up to 24 weeks
Secondary	PSA progression-free survival (PSA PFS)	from baseline until the time point at which PSA progression is confirmed or the time point of death is collected, whichever comes first.	From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
Secondary	Objective Response Rate(ORR) according to mPERCIST	defined as the proportion of participants with best overall response of complete response or partial response according to RECIST 1.1	baseline up to 24 weeks
Secondary	Best overall response(BOR) according to RECIST 1.1 and mPERCIST criteria	defined as the best response among all responses at each time point from the start date of Lu-177-DGUL administration.	baseline up to 24 weeks
Secondary	Waterfall plot according to best PSA response	% change in PSA with the highest percentage decrease in PSA values from baseline.	baseline up to 24 weeks
Secondary	Disease Control Rate(DCR) according to RECIST 1.1 and mPERCIST criteria	defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) according to RECIST v1.1.	baseline up to 24 weeks
Secondary	Duration of Response(DOR) according to RECIST 1.1 and mPERCIST criteria	defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause.	From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
Secondary	PSA Doubling time	defined as the date of doubling time of PSA level from baseline.	From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
Secondary	Radiological progression-free survival (rPFS)	defined the date of first radiological evaluation of disease progression from the first day of administration of Lu-177-DGUL or the time of death, whichever comes first.	From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
Secondary	Waterfall plot according to tumor change rate	The size of the target lesion (according to RECIST v1.1) and SUVpeak (according to mPERCIST) % change compared to the baseline are plotted as a waterfall plot	baseline up to 24 weeks
Secondary	Overall survival (OS)	defined as the date from the first day of administration of Lu-177-DGUL to death	From baseline until radiographic progression or death from any cause, whicheve. assessed up to 36 months.
Secondary	Pain intensity (NRS) and opioid analgesic use		baseline up to 24 weeks
Secondary	Quality of life (QOL): EORTC QLQ-C30, EORTC QLQ-PR25, EQ-5D-5L		baseline up to 24 weeks