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Closed (no longer recruiting)Last updated: 7 February 2024

This phase I trial is trying to understand how safe and effective a targeted therapy (HP518) is in people with prostate cancer.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

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 patients with metastatic, castration-resistant prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

I

More information

Trial Identifiers

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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

Eligibility

Inclusion

  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.

Exclusion

  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.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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