A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

Study Overview
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Brief Summary
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This is an open label, non-randomized, Phase I, dose escalation/dose expansion study of PCUR-101 in combination with androgen suppression therapy in the patients with metastatic CRPC

Official Title
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A Phase I Study of PCUR-101 in Combination With Androgen Suppression Therapy in the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

Conditions
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Metastatic Castration-Resistant Prostate Cancer

Intervention / Treatment
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* Drug: PCUR - 101


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed diagnosis of metastatic CRPC standard of care androgen deprivation treatment castrate serum level of testosterone of ≤ 50 ng/dL (≤ 1.73 mmol/L) progressive disease while receiving androgen deprivation therapy previously treated with abiraterone, enzalutamide alone or in combination AND must have demonstrated evidence of objective progression as per PCWG3 criteria adequate hematologic, renal and hepatic function KPS of ≥ 70 or ECOG of 0 to 1 Exclusion Criteria: pure small cell, neuroendocrine or other variant (non-adenocarcinoma) prostate cancer histology use of opiate analgesics for prostate cancer pain within 4 week of treatment start more than one sequential second generation AR-directed therapy received cytotoxic chemotherapy for either metastatic HSPC or CRPC within the last 12 weeks or other investigational agents within 4 weeks history of bleeding disorder history of seizure disorder concomitant use of therapeutic anticoagulation history of or current cardiac issues received external beam radiation therapy within 4 weeks CTCAE Grade > 2 neuropathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Level 1 (50 mg) PCUR-101<br>Starting Dose, 3+3 Cohort Design | Drug: PCUR - 101<br>* PCUR-101 Capsules 25 mg are solid dosage forms for oral administration<br>|
| Experimental: Level 2 (100 mg) PCUR-101<br> | Drug: PCUR - 101<br>* PCUR-101 Capsules 25 mg are solid dosage forms for oral administration<br>|
| Experimental: Level 3 (150 mg) PCUR-101<br> | Drug: PCUR - 101<br>* PCUR-101 Capsules 25 mg are solid dosage forms for oral administration<br>|
| Experimental: Level 4 (200 mg) PCUR-101<br> | Drug: PCUR - 101<br>* PCUR-101 Capsules 25 mg are solid dosage forms for oral administration<br>|
| Experimental: Level 5 (250 mg) PCUR-101<br> | Drug: PCUR - 101<br>* PCUR-101 Capsules 25 mg are solid dosage forms for oral administration<br>|
| Experimental: Level 6 (300 mg) PCUR-101<br> | Drug: PCUR - 101<br>* PCUR-101 Capsules 25 mg are solid dosage forms for oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities and Adverse Events | determined by type and severity using the most recent version of the CTCAE criteria | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response | a combination of the revised RECIST 1.1 criteria and the guidelines for Prostate Cancer Working Group 3 (PCWG3) Criteria | up to 2 years | 
| Toxicities and adverse events | determined by type and severity using the most recent version of the CTCAE criteria | up to 2 years |