A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorHinova Pharmaceuticals Inc.
About this trial
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 criteria
Qualifiers
Male, age ≥18
Patients with androgen receptor (AR) ligand binding domain (LBD) activation mutations (the dose expansion part of stage II)
Has histologically confirmed adenocarcinoma of the prostate, but there are no known significant neuroendocrine differentiation or small cell characteristics.
Has metastatic disease documented by 2 or more bone lesions by bone scan or soft tissue disease progression observed by CT/MRI at the beginning of study.
Disqualifiers
Combination of research or commercially available drugs targeting AR
Has had any other anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177LuPSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.
Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
Has significant cardiovascular disease.
Trial design
Treatments tested in this trial
- HP518 - Dose Escalation
- HP518 - Dose Escalation
- HP518 -Dose Expansion
Treatment groups
84 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov