Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
This is an open-label dose escalation and dose expansion study. Part 1 of the study (dose escalation) consists of 6 cohorts. Each cohort will be assigned a different dose level of HP518: either 25mg/d, 50mg/d, 100mg/d, 200mg/d, 300mg/d or 400mg/d. In all cohorts, HP518 will be administered orally, once daily in 28-day cycles. In Part 2 of the study (dose expansion), participants will receive HP518 orally, once daily in 28-day cycles at the highest dosage level with acceptable toxicity (RP2D) based on the data from Part 1 of the study.
Conditions
This trial is treating people with metastatic, castration-resistant prostate cancer
Eligibility
Inclusion
- Has histologically confirmed adenocarcinoma of the prostate.
- 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.
- Has disease progression while receiving any ADT, androgen biosynthesis inhibitors, or second-generation AR inhibitors.
- Must have recovered from toxicities related to any prior treatments
- Ongoing ADT with LHRH agonist/antagonist therapy or history of bilateral orchiectomy.
- ECOG performance status score of 0 to 1.
Exclusion
- Has received more than 1 line of chemotherapy for prostate cancer.
-
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.
- 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.
- Has gastrointestinal disorder affecting absorption (e.g., gastrectomy).
- Has significant cardiovascular disease.
- 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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Hinova Pharmaceuticals Aus Pty Ltd
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
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