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

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorGan & Lee Pharmaceuticals.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • GLR2037

    Drug

    GLR2037 administered QD for 28 day cycles.

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: GLR2037Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From signing of informed consent to 30 days after last dose (safety follow-up)
2

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

Time frame
28 Days
3

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.

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

Secondary outcomes

1

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.

Time frame
At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037
2

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.

Time frame
At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037
3

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.

Time frame
At predefined intervals throughout the GLR2037 treatment period, up to last dose of GLR2037
4

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

Evaluate PSA in patients in both dose groups

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gan & Lee Pharmaceuticals.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: