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

Trial 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

NCT ID: NCT05547061

Condition: Prostate Cancer
mCRPC

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
PSMA

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Factorial Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Lu-177-DGUL
Description: Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.
Arm group label: Phase 1 : Part B(High dose)
Arm group label: Phase 1 : Part B(Low dose)
Arm group label: Phase 2

Intervention type: Drug
Intervention name: Ga-68-NGUL
Description: Administered intravenously during screening and every 12 weeks after the first administration of Lu-177-DGUL.
Arm group label: Phase 1 : Part B(High dose)
Arm group label: Phase 1 : Part B(Low dose)
Arm group label: Phase 1 Part A(Healthy/Disease group)
Arm group label: Phase 2

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.

Criteria for eligibility:
Criteria:
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

Gender: Male

Minimum age: 19 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Chonnam National University Hwasun Hospital

Address:
City: Hwasun
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Seoul National University Hospital

Address:
City: Seoul
Zip: 03127
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Asan Medical Center

Address:
City: Seoul
Country: Korea, Republic of

Status: Recruiting

Facility:
Name: Seoul National University Bundang Hospital

Address:
City: Seoul
Country: Korea, Republic of

Status: Recruiting

Start date: April 12, 2021

Completion date: December 31, 2024

Lead sponsor:
Agency: Cellbion Co., Ltd.
Agency class: Industry

Source: Cellbion Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05547061