A Phase I Clinical Study of GLR2037 in Patients With Advanced Prostate Cancer

Korábbi kezelés

• 3\. Subjects who have used bisphosphonates or RANKL inhibitors for the treatment of bone metastases or bone-related diseases within 2 weeks prior to the first dose.
• 4\. Have received systemic immunosuppressive therapy within 2 weeks prior to the first dose.
• 5\. Use of strong inhibitors or inducers of CYP2C9 or CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to the first dose.
• 8\. Concurrent uncontrolled hypertension at screening. 9. Presence of active cardiac disease or occurrence of arterial or venous thromboembolism within 6 months prior to the first dose.
• 12.History of immunodeficiency or organ transplantation. 13.Concurrent dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug administration and absorption.
• 14.Not recovered from adverse events of prior anti-tumor therapy to ≤ Grade 1 at screening.
• 15.Known allergy to any component or excipient of GLR2037. 16.Subjects who have received palliative radiotherapy or major surgery (Grade 3-4) within 4 weeks prior to the first dose, or have participated in other drug clinical trials within 4 weeks prior to the first dose.
• 17.Plan to receive any other anti-tumor therapy during the study treatment period other than those specified in the protocol.
• 18.Any concomitant disease or other condition that, in the judgment of the investigator, poses a serious risk to the safety of the subject or could affect the subject's completion of the study. "

Más betegség

• 7\. Severe bone injury caused by bone metastases of prostate cancer as judged by the investigator.

Laborértékek

• 10\. History of other malignancies within 5 years prior to the first dose. 11. Have active hepatitis B (HBsAg positive and HBV-DNA titer ≥ 1×10³ copies/mL), hepatitis C (HCV antibody positive); or severe infections requiring antibiotics, antiviral or antifungal drugs for control.

Egyéb

• 6\. Patients with imaging evidence of brain or central nervous system metastases.

• Male, aged ≥ 18 years.
• Histologically or cytologically confirmed adenocarcinoma of the prostate, without neuroendocrine or small cell features.
• Metastatic bone or soft tissue lesions documented by imaging.
• Prior surgical or medical castration.
• Castrate level of testosterone at screening (≤ 50 ng/dL or 1.73 nmol/L).
• Phase Ia and Ib: Prior treatment with at least one novel endocrine therapy (e.g., abiraterone, enzalutamide, apalutamide, darolutamide, rezlutamide, etc.); patients in the dose-escalation phase of Phase Ia must have received at least one prior line of chemotherapy (e.g., docetaxel, cabazitaxel, etc.).
• Evidence of disease progression during castration therapy in patients with metastatic prostate cancer at screening.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Adequate organ function meeting protocol-specified criteria.
• Life expectancy ≥ 3 months.
• Fertile male subjects and their partners must agree to use effective contraception (e.g., condoms) and refrain from donating sperm from the first dose of the study drug until 3 months after the last dose.
• Willing to participate in this clinical trial, understand the study procedures, and have signed the informed consent form.