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

December 9, 2024 updated by: Cellbion Co., Ltd.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
91

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Hwasun, Korea, Republic of
        • Chonnam National University Hwasun Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 03127
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1 Part A(Healthy/Disease group)
Subjects are administered intravenously a single dose of 2MBq/kg of Ga-68-NGUL.
Drug: Ga-68-NGUL
Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.
Experimental: Phase 2
Subjects with positive lesions for Ga-68-NGUL are administered intravenously with Lu-177-DGUL with the determined RP2D.
Drug: Ga-68-NGUL
Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.
Drug: Lu-177-DGUL
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.
Experimental: 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.
Drug: Ga-68-NGUL
Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.
Drug: Lu-177-DGUL
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.
Experimental: 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.
Drug: Ga-68-NGUL
Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.
Drug: Lu-177-DGUL
Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate(ORR) according to RECIST 1.1
Time Frame: 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
From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PSA response rate(> 50% reduction compared to PSA before treatment)
Time Frame: baseline up to 24 weeks
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
PSA % change
Time Frame: baseline up to 24 weeks
defined as the % change of PSA level compared to baseline.
baseline up to 24 weeks
Objective Response Rate(ORR) according to mPERCIST
Time Frame: baseline up to 24 weeks
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
Best overall response(BOR) according to RECIST 1.1 and mPERCIST criteria
Time Frame: baseline up to 24 weeks
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
Waterfall plot according to best PSA response
Time Frame: baseline up to 24 weeks
% change in PSA with the highest percentage decrease in PSA values from baseline.
baseline up to 24 weeks
Disease Control Rate(DCR) according to RECIST 1.1 and mPERCIST criteria
Time Frame: baseline up to 24 weeks
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
Waterfall plot according to tumor change rate
Time Frame: baseline up to 24 weeks
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
Pain intensity (NRS) and opioid analgesic use
Time Frame: baseline up to 24 weeks
baseline up to 24 weeks
Quality of life (QOL): EORTC QLQ-C30, EORTC QLQ-PR25, EQ-5D-5L
Time Frame: baseline up to 24 weeks
baseline up to 24 weeks
PSA progression-free survival (PSA PFS)
Time Frame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
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
Duration of Response(DOR) according to RECIST 1.1 and mPERCIST criteria
Time Frame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
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
PSA Doubling time
Time Frame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
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
Radiological progression-free survival (rPFS)
Time Frame: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months
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
Overall survival (OS)
Time Frame: From baseline until radiographic progression or death from any cause, whicheve. assessed up to 36 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cellbion Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Lu-PSMA001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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