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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05252364




Registration number
NCT05252364
Ethics application status
Date submitted
3/12/2021
Date registered
23/02/2022

Titles & IDs
Public title
A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer
Scientific title
A Phase 1 Open-Label Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer
Secondary ID [1] 0 0
HP518-CS-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HP518 - Dose Escalation
Treatment: Drugs - HP518 - Dose expansion

Experimental: Part 1 - Dose Escalation, 25mg/d (Cohort 1) - Oral tablet(s), once daily in 28-day cycles

Experimental: Part 1 - Dose Escalation 100mg/d (Cohort 2) - Oral tablet(s), once daily in 28-day cycles

Experimental: Part 1 - Dose Escalation 200mg/d (Cohort 3) - Oral tablet(s), once daily in 28-day cycles

Experimental: Part 1 - Dose Escalation 300mg/d (Cohort 4) - Oral tablet(s), once daily in 28-day cycles

Experimental: Part 1 - Dose Escalation 400mg/d (Cohort 5) - Oral tablet(s), once daily in 28-day cycles

Experimental: Part 1 - Dose Escalation 500mg/d (Cohort 6) - Oral tablet(s), once daily in 28-day cycles

Experimental: Part 2 - Dose Expansion - Oral tablet(s), once daily in 28-day cycles


Treatment: Drugs: HP518 - Dose Escalation
Part 1: Dose escalation

Daily oral dosage with the prescribed dose level based on Cohort assignment.

Treatment: Drugs: HP518 - Dose expansion
Part 2: Dose expansion

Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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 drug
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Incidence of Treatment-Emergent Adverse Events characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness
Timepoint [2] 0 0
Through study completion, an average of 1 year
Primary outcome [3] 0 0
Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Timepoint [3] 0 0
Through study completion, an average of 1 year
Primary outcome [4] 0 0
Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
Timepoint [4] 0 0
Time Frame: Through study completion, an average of 1 year
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
Through study completion, an average of 1 year
Primary outcome [6] 0 0
Proportion of patients showing a PSA decline of =50% between baseline and Week 12 of dosing with HP518.
Timepoint [6] 0 0
12 weeks
Secondary outcome [1] 0 0
Assessment of pharmacokinetic parameters of HP518 : area under the concentration-time curve (AUC)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Assessment of pharmacokinetic parameters of HP518: Maximum concentration (Cmax)
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Assessment of pharmacokinetic parameters of HP518: Time to maximum concentration (Tmax)
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Assessment of pharmacokinetic parameters of HP518: apparent terminal elimination half-life (T1/2)
Timepoint [4] 0 0
12 weeks
Secondary outcome [5] 0 0
Assessment of pharmacokinetic parameters of HP518: apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Assessment of pharmacokinetic parameters of HP518: oral clearance (CL/F)
Timepoint [6] 0 0
12 weeks
Secondary outcome [7] 0 0
Assessment of PSA50 from baseline to after 4 and 8 weeks of dosing with HP518
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Time to PSA progression using the PCWG3 definition (PSA >25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart)
Timepoint [8] 0 0
Through study completion, an average of 1 year
Secondary outcome [9] 0 0
Time to radiographic progression using the RECIST v1.1 and PCWG3 definition
Timepoint [9] 0 0
Through study completion, an average of 1 year
Secondary outcome [10] 0 0
Radiographic response measured by RECIST 1.1 in patients with measurable soft tissue disease at baseline
Timepoint [10] 0 0
Through study completion, an average of 1 year
Secondary outcome [11] 0 0
Change in number of AR N-term-positive CTCs/ml from baseline to week 12
Timepoint [11] 0 0
12 weeks
Secondary outcome [12] 0 0
Genomic profiling using cfDNA
Timepoint [12] 0 0
12 weeks

Eligibility
Key inclusion criteria
1. Has histologically confirmed adenocarcinoma of the prostate.
2. Has metastatic disease at study entry documented by 2 or more bone lesions on bone scan or by soft tissue disease observed by CT/MRI.
3. Has disease progression while receiving any ADT, androgen biosynthesis inhibitors, or second-generation AR inhibitors.
4. Must have recovered from toxicities related to any prior treatments
5. Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
6. ECOG performance status score of 0 to 1.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has received more than 1 line of chemotherapy for prostate cancer.
2. Use of enzalutamide, and/or other second-generation AR inhibitors and/or abiraterone as follows:

* Received any agent within 4 weeks prior to the start of study drug.
* Discontinued agent without evidence of radiographic or PSA progression.
3. Has had any anticancer treatments, including immunotherapy, chemotherapy, or radiotherapy (eg, 177Lu-PSMA-617, radium 223, PARP inhibitor) within 4 weeks prior to the first dose of HP518.
4. Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
5. Has significant cardiovascular disease.
6. Use of an investigational agent, without evidence of radiographic or PSA progression, within 4 weeks prior to the first dose of HP518 or a period required by local regulation, whichever is longer.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/01/2024
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [4] 0 0
Peter McCallum Cancer Center - Melbourne
Recruitment hospital [5] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment postcode(s) [5] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hinova Pharmaceuticals Aus Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Zhonghua Zhou
Address 0 0
Hinova Pharmaceuticals USA, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05252364