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MCRPCPhase 3NCT03851640

A Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC).

A Phase 3 study testing HC-1119 in people with MCRPC, run by Hinova Pharmaceuticals Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
MCRPC
What is being tested?
HC-1119
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
417 participants
Where
1 siteChina
Study dates
12 Apr 2019to Sep 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males aged ≥18 years at screening and voluntary to participate in the study and sign the informed consent form.
  • Subjects with histologically or cytologically confirmed prostate adenocarcinoma, with no small cell features.
  • In the case of medical or surgical castration, during or after the last treatment before screening, there are signs of progressive disease determined according to the PCWG3 criteria, defined as satisfying one or more of the following 3 criteria:
  • PSA progression; at least 2 episodes of increased PSA levels that are measured ≥1 week apart; PSA ≥ 1 μg/L (1 ng/mL) in the screening period;
  • Progression of soft tissue lesions as defined by RECIST 1.1;
  • The progression of bone lesions is defined as at least two new lesions discovered by bone scan; ambiguous results can be confirmed using another imaging technique (e.g., CT or MRI).
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  • Metastatic diseases confirmed by imaging examinations during the screening period (the status of metastasis refers to the presence of metastatic lesions confirmed by bone scan and/or CT/MRI scan).
  • For patients who have undergone orchiectomy or are being treated by medical castration therapy, their androgen blockade therapy is maintained by luteinizing hormone-releasing hormone agonists or antagonists during the study period (including the follow-up period), and their serum testosterone levels are ≤ 1.73 nmol/L (50 ng/dL) during screening visits.
  • Patients who have failed previous treatments of prostate cancer with abiraterone acetate or who are intolerant to treatments with abiraterone acetate.
  • Patients who have failed previous chemotherapy of prostate cancer with docetaxel or who are intolerant to treatments with docetaxel, or who are not suitable for docetaxel treatment during screening. Patients who are not suitable for docetaxel treatment during screening and do not plan to use cytotoxic chemotherapy within 6 months after the informed discussion are eligible.
  • Expected survival of ≥ 3 months.
  • ECOG performance status score of 0-2.
  • Laboratory tests must meet the following criteria:
  • Blood routine examination: Hemoglobin (Hb) ≥ 85 g/L; white blood cell (WBC) ≥ 3.0 x 109/L; platelet (PLT) ≥ 75 x 109/L;
  • Liver function: Total bilirubin (TBIL) ≤ 1.5 x ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (for patients without liver metastasis) or ≤ 5 x ULN (for patients with liver metastasis); albumin (ALB) ≥ 25 g/L;
  • Renal function: serum creatinine (SCr) ≤ 1.5 x ULN.
  • Willing to use reliable contraceptive measures (such as condoms) and not to donate sperms throughout the study period and within 3 months after the last dose.

Who cannot join

  • Subjects with any of the following conditions should not be enrolled:
  • Received any anti-prostate cancer treatment within 4 weeks before randomization, including chemotherapy, immunotherapy, targeted therapy, estrogen therapy, anti-androgen therapy, systemic radiotherapy, treatments with traditional Chinese medicines for anticancer, or treatments with interventional drugs of other clinical trials; palliative radiotherapy or surgery for bone metastatic or soft tissue lesions should be completed >14 days prior to baseline imaging examinations; the lesions treated by palliative radiotherapy should not be the targeted lesions of subsequent RECIST 1.1 assessment. Androgen blockade therapy that is maintained by a luteinizing hormone releasing hormone agonist or antagonist.
  • Previously received any of novel androgen receptor inhibitors (e.g., Enzalutamide, Apalutamide, Darolutamide, SHR3680, Proxalutamide, or HC-1119).
  • Patients with brain or central nervous system metastases are known (if a brain or central nervous system metastasis is suspected, a CT/MRI scan of the head is required)
  • Patients with known serious cardiovascular diseases, including any of the following:
  • A myocardial infarction or thrombotic event occurred in the past 6 months;
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  • Known unstable angina;
  • Heart failure of Grade III or IV according to the New York Heart Association (NYHA) criteria;
  • QT interval of > 500 ms during screening visits;
  • Resting systolic blood pressure of >170 mmHg or diastolic blood pressure of >105 mmHg suggesting uncontrolled hypertension during screening visits.
  • The toxicity of previous treatment has not been eliminated before the start of the study treatment; toxic reaction of grade 2 or above (except for hair loss) according to the CTCAE 5.0 grading scale remains.
  • Clinically significant gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (for example, inability to swallow, chronic diarrhea or intestinal obstruction, and patients had total gastrectomy).
  • Patients with a history of serious diseases in the central nervous system. Patients with a history of epilepsy or any history of diseases that may induce epilepsy, including unexplained loss of consciousness or transient ischemic attack.
  • Patients who have been diagnosed in the past 5 years with other malignant tumors in addition to prostate cancer, except patients with cured basal or squamous cell skin cancer and superficial bladder tumors (Ta, Tis, and T1).
  • Patients with a history of allogeneic bone marrow or organ transplantation who require continued medical treatment.
  • Patients with known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis or other active infections.
  • Patients known to be allergic to androgen receptor inhibitors.
  • The investigator believes that the patients are unfit for this study (e.g., the treatments will not benefit the patients the most, inadequate patient compliance, etc.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yi Zhou contact

+86 1821 5530 757

yzhou@hinovapharma.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Ye DingWei

    Recruiting

Other trials in China

About this study

Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HC-1119 Soft Capsules in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Failed Treatments with Abiraterone Acetate and Docetaxel.

This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical study evaluating the efficacy and safety of HC-1119 soft capsules versus placebo in mCRPC patients who have failed or become intolerant to the treatments with both abiraterone acetate and docetaxel, or who are not suitable for docetaxel treatment.

Conditions
MCRPC
Being tested
HC-1119, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HC-1119Drug

    oral

  • placeboDrug

    oral

Study groups in NCT03851640
Study groupRoleWhat they receive
HC-1119Experimental80mg;
Receives: Drug: HC-1119
placeboPlacebo comparator80mg;
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic Progression-Free Survival (rPFS)

    Measured: From signing informed consent up to approximately 30 months

Secondary outcomes (7)

  1. Overall Survival (OS)

    Measured: From signing informed consent up to approximately 30 months

  2. Time to progression (TTP)

    Measured: From signing informed consent up to approximately 30 months

  3. Objective response rate (ORR)

    Measured: From signing informed consent up to approximately 30 months

  4. Disease control rate (DCR)

    Measured: From signing informed consent up to approximately 30 months

  5. Response rate of prostate specific antigen (PSA)

    Measured: From signing informed consent up to approximately 30 months

  6. Time to prostate specific antigen(PSA) progression (TTPP)

    Measured: From signing informed consent up to approximately 30 months

  7. Number of patients with adverse events

    Safety measures

    Measured: From signing informed consent up to approximately 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start12 Apr 2019
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
417 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03851640
Sponsor's protocol ID
HC-1119-04
Status last verified
Nov 2024
First submitted
17 Feb 2019
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wu J, Li X, Gu C, Hua L, Liu R, Li J, Qiu M, Guo J, Dong H, Ji Z, Xie L, Zhu S, Zhang X, Chen P, Jiang S, Sun Z, Xu D, Chen H, Shi B, Wang Y, Pu J, Perabo F, Chen Y, Ye D. Deutenzalutamide, a novel androgen receptor inhibitor, after progression on docetaxel and abiraterone in metastatic castration-resistant prostate cancer: results from the randomized phase III HC-1119-04 trial. Signal Transduct Target Ther. 2026 Apr 13;11(1):131. doi: 10.1038/s41392-026-02618-3.

    PubMed 41968137

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HC-1119 in people with MCRPC, run by Hinova Pharmaceuticals Inc. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi Zhou (+86 1821 5530 757, yzhou@hinovapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiographic Progression-Free Survival (rPFS) (time frame: From signing informed consent up to approximately 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03851640, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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