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AzTrials

Prostate CancerPhase 1/2NCT05547061

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

A Phase 1/2 study testing Lu-177-DGUL and Ga-68-NGUL in people with Prostate Cancer and mCRPC, run by Cellbion Co., Ltd. at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 19 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer, mCRPC
What is being tested?
Lu-177-DGUL and Ga-68-NGUL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
4 sitesSouth Korea
Study dates
12 Apr 2021to 28 Feb 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Chonnam National University Hwasun Hospital

    Hwasun

  • Seoul National University Hospital

    Seoul, 03127

  • Asan Medical Center

    Seoul

  • Seoul National University Bundang Hospital

    Seoul

Other trials in South Korea

About this study

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.

Being tested
Lu-177-DGUL, Ga-68-NGUL
Keywords
PSMA
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lu-177-DGULDrug

    Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.

  • Ga-68-NGULDrug

    Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.

Study groups in NCT05547061
Study groupRoleWhat they receive
Phase 1 Part A(Healthy/Disease group)ExperimentalSubjects are administered intravenously a single dose of 2MBq/kg of Ga-68-NGUL.
Receives: Drug: Ga-68-NGUL
Phase 1 : Part B(Low dose)ExperimentalSubjects with positive lesions for Ga-68-NGUL are administered intravenously with low dose(150mCi) of Lu-177-DGUL.
Receives: Drug: Lu-177-DGUL; Drug: Ga-68-NGUL
Phase 1 : Part B(High dose)ExperimentalSubjects with positive lesions for Ga-68-NGUL are administered intravenously with high dose(200mCi) of Lu-177-DGUL.
Receives: Drug: Lu-177-DGUL; Drug: Ga-68-NGUL
Phase 2ExperimentalSubjects with positive lesions for Ga-68-NGUL are administered intravenously with Lu-177-DGUL with the determined RP2D.
Receives: Drug: Lu-177-DGUL; Drug: Ga-68-NGUL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months

Secondary outcomes (14)

  1. 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

    Measured: baseline up to 24 weeks

  2. PSA % change

    defined as the % change of PSA level compared to baseline.

    Measured: baseline up to 24 weeks

  3. 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.

    Measured: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months

  4. 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

    Measured: baseline up to 24 weeks

  5. 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.

    Measured: baseline up to 24 weeks

  6. Waterfall plot according to best PSA response

    % change in PSA with the highest percentage decrease in PSA values from baseline.

    Measured: baseline up to 24 weeks

  7. 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.

    Measured: baseline up to 24 weeks

  8. 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.

    Measured: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months

  9. PSA Doubling time

    defined as the date of doubling time of PSA level from baseline.

    Measured: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months

  10. 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.

    Measured: From baseline until radiographic progression or death from any cause, whichever comes first. assessed up to 36 months

  11. 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

    Measured: baseline up to 24 weeks

  12. Overall survival (OS)

    defined as the date from the first day of administration of Lu-177-DGUL to death

    Measured: From baseline until radiographic progression or death from any cause, whicheve. assessed up to 36 months.

  13. Pain intensity (NRS) and opioid analgesic use

    Measured: baseline up to 24 weeks

  14. Quality of life (QOL): EORTC QLQ-C30, EORTC QLQ-PR25, EQ-5D-5L

    Measured: baseline up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2022
  2. Study start12 Apr 2021
  3. Primary completion30 Jul 2025
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05547061
Sponsor's protocol ID
Lu-PSMA001
Status last verified
Oct 2026
First submitted
13 Sep 2022
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lu-177-DGUL and Ga-68-NGUL in people with Prostate Cancer and mCRPC, run by Cellbion Co., Ltd. at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05547061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.

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