A Study of SHR-4394 Injection in Subjects With Prostate Cancer
A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
1 other identifier
interventional
240
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 prostate-cancer
Started Jan 2025
Shorter than P25 for phase_1 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2025
CompletedFirst Posted
Study publicly available on registry
January 20, 2025
CompletedStudy Start
First participant enrolled
January 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 27, 2025
February 1, 2025
2.1 years
January 14, 2025
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Dose-limiting toxicity (DLT)
3 weeks.
Maximal tolerable dose (MTD)
3 weeks.
Adverse events (AEs)
Screening up to study completion, an average of 1 year.
Recommended phase II dose (RP2D)
Screening up to study completion, an average of 1 year.
Secondary Outcomes (4)
Objective response rate (ORR)
Up to approximately 2 years.
Duration of response (DOR)
Up to approximately 2 years.
Disease control rate (DCR)
Up to approximately 2 years.
overall survival (OS)
Up to approximately 2 years.
Study Arms (1)
SHR4394
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2025
First Posted
January 20, 2025
Study Start
January 22, 2025
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
February 27, 2025
Record last verified: 2025-02