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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

NCT ID: NCT05547061

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer mCRPC

Keywords

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PSMA

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 Part A(Healthy/Disease group)

Subjects are administered intravenously a single dose of 2MBq/kg of Ga-68-NGUL.

Group Type EXPERIMENTAL

Ga-68-NGUL

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Lu-177-DGUL

Intervention Type DRUG

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

Ga-68-NGUL

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Lu-177-DGUL

Intervention Type DRUG

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

Ga-68-NGUL

Intervention Type DRUG

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

Phase 2

Subjects with positive lesions for Ga-68-NGUL are administered intravenously with Lu-177-DGUL with the determined RP2D.

Group Type EXPERIMENTAL

Lu-177-DGUL

Intervention Type DRUG

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

Ga-68-NGUL

Intervention Type DRUG

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

Interventions

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Lu-177-DGUL

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

Intervention Type DRUG

Ga-68-NGUL

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cellbion Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chonnam National University Hwasun Hospital

Hwasun, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Seoul National University Bundang Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Lu-PSMA001

Identifier Type: -

Identifier Source: org_study_id