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

Conditions: Prostate Cancer; mCRPC

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.


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

Keywords: psma