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

NCT07468396 | Not Yet Recruiting Phase 1

• 1 other identifier: GLR2037-PC-101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Number of patients with Adverse Events as a measure of safety and tolerability of GLR2037

  Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 6.0), timing, seriousness, and relationship to study drug.

  From signing of informed consent to 30 days after last dose (safety follow-up)

• Incidence of DLT of GLR2037

  First Cycle Dose limiting toxicities characterized by type, frequency, severity(as graded by NCI CTCAE version 6.0), timing, seriousness, and relationship to study drug

  28 Days

• Incidence of laboratory abnormalities as a measure of safety and tolerability of GLR2037

  Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.

  From signing of informed consent to 30 days after last dose (safety follow-up)

Secondary Outcomes (4)

• Assessment of pharmacokinetic (PK) parameter area under the concentration-time curve (AUC).

  At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037

• Assessment of pharmacokinetic parameter maximum concentration (Cmax).

  At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037

• Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)

  At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037

• To evaluate the clinical anti-tumor activity of GLR2037 in patients with mCRPC

  12 Weeks

Study Arms (1)

GLR2037

EXPERIMENTAL

GLR2037 administered one daily(QD) for 28 day cycles.

Drug: GLR2037

Interventions

GLR2037 DRUG

GLR2037 administered QD for 28 day cycles.

GLR2037

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. Have received systemic immunosuppressive therapy within 2 weeks prior to the first dose.
• \. 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.
• \. Patients with imaging evidence of brain or central nervous system metastases.
• \. Severe bone injury caused by bone metastases of prostate cancer as judged by the investigator.
• \. 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.
• \. 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.
• History of immunodeficiency or organ transplantation. 13.Concurrent dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug administration and absorption.
• Not recovered from adverse events of prior anti-tumor therapy to ≤ Grade 1 at screening.
• 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.
• Plan to receive any other anti-tumor therapy during the study treatment period other than those specified in the protocol.
• 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. "

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

No.8 Nanfeng West 1st Street, Huoxian, Tongzhou District

Beijing, China

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

Central Study Contacts

Yunda Zhuge

CONTACT

13705398525; zhugeyunda@ganlee.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 12, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2031
• Study Completion (Estimated): April 30, 2033
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (1)