TheranosticTrials.org

Clinical Trial · NCT07795268

Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Overview

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-NYM032 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

Sponsor

Norroy Bioscience Co., LTD

Phase

Phase 3

ClinicalTrials.gov

NCT07795268

Drug / Compound

NYM032

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Soft-tissue progression defined \[PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)\]
  • Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization.
  • Patients must have a life expectancy ≥ 6 months.
  • Patient's serum/plasma testosterone level must be at a castrate level (\<50 ng/dL or \<1.7 nmol/L).
  • Albumin \>3.0 g/dL (3.0 g/dL is equivalent to 30 g/L)
  • Hepatic:
  • Patients must have an ECOG performance status of 0 to 2.
  • Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L (1.5 x 10\^9/L is equivalent to 1.5 x 10\^3/µL and 1.5 x K/µL and 1.5 x 10\^3/cumm and 1500/µL)
  • Participants must have been previously treated with at least 1 novel androgen receptor pathway inhibitor (ARPI) (e.g., abiraterone and/or enzalutamide) and at least 1, but no more than 2, previous taxane-based chemotherapy regimens. A taxane-based chemotherapy regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane-based chemotherapy regimen, the participant is eligible : if the participant is unwilling to receive a second taxane-based chemotherapy regimen or if the participant's physician deems the participant unsuitable to receive a second taxane-based chemotherapy regimen (e.g., frailty assessed by geriatric or health status evaluation, intolerance, etc.).
  • Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
  • Platelets≥ 100 x 10\^9/L (100 x 10\^9/L is equivalent to 100 x 10\^3/µL and 100 x K/µL and 100 x 10\^3/cumm and 100,000/µL)
  • For patients who have partners of childbearing potential:Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration. Patients must not donate sperm during this period.
  • White blood cell (WBC) count ≥2.5 x 109/L
  • Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted
  • Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases
  • Hemoglobin≥ 10.0 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L)
  • Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
  • Renal:
  • Progression of bone disease: appearance of 2 or more new bone lesions on bone scan (PCWG3 criteria (Scher et al 2016))
  • Serum creatinine ≤1.5 x ULN and creatinine clearance ≥50 mL/min
  • Patients must have adequate organ function:
  • Patients must have a positive 68Ga-NYM032 PET/CT scan.
  • Bone marrow reserve:

Exclusion

  • Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\], excluding ARPI therapy;) anticancer device therapy, radiation therapy, or an investigational drug in a clinical study within 4 weeks prior to day of randomization.
  • Uncontrolled or clinically significant cardiovascular disease, including but not limited to:
  • Clinically significant concomitant pulmonary diseases, including but not limited to:
  • Severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or other related conditions. Note: Participants with bladder outlet obstruction or urinary incontinence that can be managed with available best standard of care (including urinary pads, drainage, etc.) are eligible for study participation.
  • Previous PSMA-targeted radioligand therapy is not allowed.