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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
HP518 - Dose Escalation
DrugPart 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
HP518 - Dose Escalation
DrugPart 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort
HP518 -Dose Expansion
DrugPart 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.
Treatment groups
84 Participants
are divided into 3 treatment groupsGroup A: Part 1 - Dose Escalation, 400mg/d (Cohort1)Experimental treatment 1 intervention
Group B: Part 1 - Dose Escalation 500mg/d (Cohort 2)Experimental treatment 1 intervention
Group C: Part 2 - Dose Expansion Oral tablet(s)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)
To evaluate the safety and tolerability and determine the MTD and the RP2D of orally administered HP518 (Part 1)
Time frame
28 DAYS2
Incidence of Treatment-Emergent Adverse Events characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness
To evaluate the safety of orally administered HP518 (Part 1)
Time frame
Through study completion, an average of 1 year3
Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
To evaluate the safety of orally administered HP518 (Part 1)
Time frame
Through study completion, an average of 1 year4
Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
To evaluate the safety of orally administered HP518 (Part 1)
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
area under the concentration-time curve (AUC)
Assessment of pharmacokinetic parameters of HP518
Time frame
12 weeks2
Maximum concentration (Cmax)
Assessment of pharmacokinetic parameters of HP518
Time frame
12 weeks3
Time to maximum concentration (Tmax)
Assessment of pharmacokinetic parameters of HP518
Time frame
12 weeks4
Apparent terminal elimination half-life (T1/2)
Assessment of pharmacokinetic parameters of HP518
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov