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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

April 12, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 9, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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