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

ConditionMCRPC

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexMale

Age18+

SponsorHinova Pharmaceuticals Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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;

Disqualifiers

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)

A myocardial infarction or thrombotic event occurred in the past 6 months;

Trial design

Design model

Sequential

Treatments tested in this trial

HC-1119
Drug
oral
placebo
Drug
oral

Treatment groups

417 Participants

are divided into 2 treatment groups

Group A: HC-1119Experimental treatment 1 intervention

Group B: placeboPlacebo comparator 1 intervention