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

Pellficure Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Metastatic Castration-Resistant Prostate Cancer

Treatments: Drug: PCUR - 101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03137758

PCUR101-001

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 6 patient groups

Level 1 (50 mg) PCUR-101

Experimental group

Description:

Starting Dose, 3+3 Cohort Design

Treatment:

Drug: PCUR - 101

Level 2 (100 mg) PCUR-101

Experimental group

Treatment:

Drug: PCUR - 101

Level 3 (150 mg) PCUR-101

Experimental group

Treatment:

Drug: PCUR - 101

Level 4 (200 mg) PCUR-101

Experimental group

Treatment:

Drug: PCUR - 101

Level 5 (250 mg) PCUR-101

Experimental group

Treatment:

Drug: PCUR - 101

Level 6 (300 mg) PCUR-101

Experimental group

Treatment:

Drug: PCUR - 101