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

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This clinical trial is an open-label, single-arm, single-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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cellbion Co., Ltd.

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 12 weeks 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