Prostate CancerPhase 1NCT07468396
A Phase I Clinical Study of GLR2037 in Patients With Advanced Prostate Cancer
A Phase 1 study testing GLR2037 in people with Prostate Cancer, run by Gan & Lee Pharmaceuticals. at 1 site in China.
Trial summary
A Phase I Clinical Study of GLR2037 in Patients with Advanced Prostate Cancer Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- GLR2037
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 30 Apr 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.).
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- 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.
- Exclusion Criteria:"1. Prior use of AR protein degraders. 2. Use of any other biological and/or immunological anti-tumor therapy (except castration therapy), targeted therapy, estrogen therapy, anti-androgen therapy, or other interventional investigational drug therapy; or receipt of systemic chemotherapy, systemic radiotherapy, or Chinese herbal/patent medicine with anti-tumor indications (as clearly stated in the package insert) within 4 weeks (or 5 half-lives, whichever is shorter) prior to the first dose; or receipt of nitrosoureas, bicalutamide, or nilutamide within 6 weeks (or 5 half-lives, whichever is shorter) prior to the first dose.
- 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.
- 6. Patients with imaging evidence of brain or central nervous system metastases.
- 7. Severe bone injury caused by bone metastases of prostate cancer as judged by the investigator.
- 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.
- 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.
- 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. "
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No.8 Nanfeng West 1st Street, Huoxian, Tongzhou District
Beijing
010-56456726, zhugeyunda@ganlee.com
About this study
Official title: A Phase I, Single-arm, Open-label, Multi-center Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GLR2037 in Patients With Metastatic Prostate Cancer
A Phase I Clinical Study of GLR2037 in Patients with Advanced Prostate Cancer
- Conditions
- Prostate Cancer
- Being tested
- GLR2037
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLR2037Drug
GLR2037 administered QD for 28 day cycles.
| Study group | Role | What they receive |
|---|---|---|
| GLR2037 | Experimental | GLR2037 administered one daily(QD) for 28 day cycles. Receives: Drug: GLR2037 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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).
Concentration-time curve (AUC) for single dose of GLR2037 PK parameters will be assessed when applicable after a single dose and after multiple doses.
Measured: At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037
Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Maximum concentration (Cmax) for single and multiple dose of GLR2037 PK parameters will be assessed when applicable after a single dose and after multiple doses.
Measured: At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037
Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
Time to maximum concentration (Tmax) for single and multiple dose of GLR2037 PK parameters will be assessed when applicable after a single dose and after multiple doses.
Measured: 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
Evaluate PSA in patients in both dose groups
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Oct 2031 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Gan & Lee Pharmaceuticals.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gan & Lee Pharmaceuticals.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468396
- Sponsor's protocol ID
- GLR2037-PC-101
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-arm, Open-label, Multi-center Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GLR2037 in Patients With Metastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07468396
- Acronym / sponsor ID
- GLR2037-PC-101
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Gan & Lee Pharmaceuticals.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2031 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase I Clinical Study of GLR2037 in Patients with Advanced Prostate Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GLR2037 | Experimental | Drug: GLR2037GLR2037 administered one daily(QD) for 28 day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLR2037GLR2037 administered QD for 28 day cycles. | Drug | GLR2037 |
Primary outcome
Number of patients with Adverse Events as a measure of safety and tolerability of GLR2037
Time frame: From signing of informed consent to 30 days after last dose (safety follow-up)
Adverse Events as characterized by type, frequency, severity (as graded by NCI CTCAE version 6.0), timing, seriousness, and relationship to study drug.
Incidence of DLT of GLR2037
Time frame: 28 Days
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
Incidence of laboratory abnormalities as a measure of safety and tolerability of GLR2037
Time frame: From signing of informed consent to 30 days after last dose (safety follow-up)
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
4 secondary outcomes
Assessment of pharmacokinetic (PK) parameter area under the concentration-time curve (AUC).
Time frame: At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037
Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Time frame: At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037
Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
Time frame: 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
Time frame: 12 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GLR2037 in people with Prostate Cancer, run by Gan & Lee Pharmaceuticals. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yunda Zhuge (13705398525, zhugeyunda@ganlee.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Adverse Events as a measure of safety and tolerability of GLR2037 (time frame: From signing of informed consent to 30 days after last dose (safety follow-up)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.