Recruiting NCT06783829
A Study of SHR-4394 Injection in Subjects With Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR4394.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
Overview
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.
Interventions
- Drug SHR4394
SHR4394
Primary outcome measures
- Dose-limiting toxicity (DLT) [Time frame: 3 weeks.]
- Maximal tolerable dose (MTD) [Time frame: 3 weeks.]
- Adverse events (AEs) [Time frame: Screening up to study completion, an average of 1 year.]
- Recommended phase II dose (RP2D) [Time frame: Screening up to study completion, an average of 1 year.]
Secondary outcome measures (4)
- Objective response rate (ORR) [Time frame: Up to approximately 2 years.]
- Duration of response (DOR) [Time frame: Up to approximately 2 years.]
- Disease control rate (DCR) [Time frame: Up to approximately 2 years.]
- overall survival (OS) [Time frame: Up to approximately 2 years.]
Eligibility criteria
Inclusion criteria
- Age range: 18-85 years old, male;
- ECOG score for physical condition is 0-1 points;
- Expected survival period ≥ 6 months;
- Prostate adenocarcinoma confirmed by histological or cytological examination;
- Patients with at least one metastasis lesion;
- Disease progression on or after the most-recent prior regimen;
- Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
- Testosterone was at castration level;
- Adequate organ function.
Exclusion criteria
- Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
- Unresolved to CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy;
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Uncontrollable tumor-related pain;
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
- Other serious concomitant disease;
- Previous or co-existing malignancies;
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
- Active hepatitis B or active hepatitis C;
- Other inappropriate situation considered by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT06783829 · SHR-4394-101