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NCT Number: NCT06155084

A Study to Assess the Safety, Pharmacokinetics, and Anti-Tumor Activity of Oral HP518 in mCRPC Patients

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

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Second Hospital Of Anhui Medical University, Hefei, Anhui, China

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About this study

This First in Human dose escalation and expansion study of HP518 in patients with progressive mCRPC after NHA and chemotherapy is being conducted not only to evaluate the safety and tolerability of orally administered HP518, but also to provide preliminary efficacy for the reference of future studies.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • the progression of the disease after receiving at least one new endocrine therapy and progressing with at least first-line chemotherapy.
  • 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 criteria

  • 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.

Treatment and study plan

HP518 - Dose Escalation

Drug

Part 1: Dose escalation Daily oral dosage with the prescribed dose level based on Cohort

Other names: Part 1 - Dose Escalation

HP518 -Dose Expansion

Drug

Part 2: Dose expansion Daily oral dosage with the highest dose with acceptable toxicity (RP2D) based on data from Part 1.

Other names: Part 2 - Dose Expansion Oral tablet(s)

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)

    Time frame: 28 DAYS

    To evaluate the safety and tolerability and determine the MTD and the RP2D of orally administered HP518 (Part 1)

  2. Incidence of Treatment-Emergent Adverse Events characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness

    Time frame: Through study completion, an average of 1 year

    To evaluate the safety of orally administered HP518 (Part 1)

  3. Incidence of laboratory abnormalities, characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

    Time frame: Through study completion, an average of 1 year

    To evaluate the safety of orally administered HP518 (Part 1)

  4. Incidence of vital signs abnormalities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing

    Time frame: Through study completion, an average of 1 year

    To evaluate the safety of orally administered HP518 (Part 1)

  5. 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

    Time frame: Through study completion, an average of 1 year

    To evaluate the safety of orally administered HP518 (Part 1)

  6. PSA50 response rate

    Time frame: 12 weeks

    Proportion of patients showing a PSA decline by ≥50% between baseline and Week 12 of dosing with HP518.

Secondary outcomes

  1. area under the concentration-time curve (AUC)

    Time frame: 12 weeks

    Assessment of pharmacokinetic parameters of HP518

  2. Maximum concentration (Cmax)

    Time frame: 12 weeks

    Assessment of pharmacokinetic parameters of HP518

  3. Time to maximum concentration (Tmax)

    Time frame: 12 weeks

    Assessment of pharmacokinetic parameters of HP518

  4. Apparent terminal elimination half-life (T1/2)

    Time frame: 12 weeks

    Assessment of pharmacokinetic parameters of HP518

  5. apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

    Time frame: 12 weeks

    Assessment of pharmacokinetic parameters of HP518

  6. oral clearance (CL/F)

    Time frame: 12 weeks

    Assessment of pharmacokinetic parameters of HP518

  7. According to PCWG3

    Time frame: 8 weeks

    evaluate PSA50 response rate: PSA decline by≥50% between baseline and 4 weeks/8 weeks/12 weeks( only Part 1) of dosing with HP518

  8. According to PCWG3, evaluate time to PSA progression

    Time frame: Through study completion, an average of 1 year

    PCWG3 definition: PSA increase >25% and >2 ng/mL above nadir, confirmed by progression at 2 time points at least 3 weeks apart) nadir, confirmed by progression at 2 time points at least 3 weeks apart)

  9. Time to radiographic progression by investigator PCWG3 definition

    Time frame: Through study completion, an average of 1 year

    using the RECIST v1.1 and PCWG3 definition

  10. Evaluate the modified best overall response mBOR by investigator

    Time frame: Through study completion, an average of 1 year

    According to RECIST (version 1.1) and PCWG3

  11. analyze the efficacy of patients with different AR phenotypes(Part 2)

    Time frame: Through study completion, an average of 1 year

    According to genetic testing results

Study contacts

Contact information is provided by the study sponsor or research team.

Qianrong Xiang

CONTACT

[email protected]

+86 28 8505 8465

Sponsors and collaborators

Lead sponsor

Hinova Pharmaceuticals Inc.

Industry

Registry information

Official study title

A Phase I/II Open-Label Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral HP518 in Patients With Metastatic Castration-Resistant Prostate Cancer in China

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2023
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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