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

NCT05547061 | Active Not Recruiting Phase 1

• 1 other identifier: Lu-PSMA001
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Prostate Cancer; mCRPC

Keywords

PSMA

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (14)

• PSA response rate(> 50% reduction compared to PSA before treatment)

  baseline up to 24 weeks

• PSA % change

  baseline up to 24 weeks

• PSA progression-free survival (PSA PFS)

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

• Objective Response Rate(ORR) according to mPERCIST

  baseline up to 24 weeks

• Best overall response(BOR) according to RECIST 1.1 and mPERCIST criteria

  baseline up to 24 weeks

Study Arms (4)

Phase 1 Part A(Healthy/Disease group)

EXPERIMENTAL

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

Drug: Ga-68-NGUL

Phase 1 : Part B(Low dose)

EXPERIMENTAL

Subjects with positive lesions for Ga-68-NGUL are administered intravenously with low dose(150mCi) of Lu-177-DGUL.

Drug: Lu-177-DGUL; Drug: Ga-68-NGUL

Phase 1 : Part B(High dose)

EXPERIMENTAL

Subjects with positive lesions for Ga-68-NGUL are administered intravenously with high dose(200mCi) of Lu-177-DGUL.

Drug: Lu-177-DGUL; Drug: Ga-68-NGUL

Phase 2

EXPERIMENTAL

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

Drug: Lu-177-DGUL; Drug: Ga-68-NGUL

Interventions

Lu-177-DGUL DRUG

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

Phase 1 : Part B(High dose); Phase 1 : Part B(Low dose); Phase 2

Ga-68-NGUL DRUG

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

Phase 1 : Part B(High dose); Phase 1 : Part B(Low dose); Phase 1 Part A(Healthy/Disease group); Phase 2

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cellbion Co., Ltd.: lead

Study Sites (4)

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Location

Seoul National University Hospital

Seoul, 03127, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 21, 2022
• Study Start: April 12, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

KR (4)