A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

Condition(s) studied

Investigational drug(s) / intervention(s)

HP518 - Dose Escalation: Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort

HP518 - Dose Escalation: Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort

HP518 -Dose Expansion: Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.

Study summary

The overall objective of this Phase 1 study is to evaluate the safety, PK,and anti-tumor activity of daily oral dosing with HP518,selecting the RP2D of HP518 based on assessments of patients with progressive mCRPC in dose-escalation phase

Eligibility

Primary outcome measure(s)

• Incidences of Protocol-defined DLT during the DLT assessment period , characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drugorally administered HP518 (Part 1) — 28 DAYS
  To evaluate the safety and tolerability and determine the MTD and the RP2D of orally administered HP518 (Part 1)
• Incidence of Treatment-Emergent Adverse Events characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness — Through study completion, an average of 1 year
  To evaluate the safety of orally administered HP518 (Part 1)
• Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing — Through study completion, an average of 1 year
  To evaluate the safety of orally administered HP518 (Part 1)
• Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing — Through study completion, an average of 1 year
  To evaluate the safety of orally administered HP518 (Part 1)
• Incidence of ECG (PR, QRS, QT, and QTcF intervals) abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing — Through study completion, an average of 1 year
  To evaluate the safety of orally administered HP518 (Part 1)
• PSA50 response rate — 12 weeks
  Proportion of patients showing a PSA decline by ≥50% between baseline and Week 12 of dosing with HP518.

Trial sites (27)

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