A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-6914 Injection in Participants With Prostate Cancer
1 other identifier
interventional
118
1 country
1
Brief Summary
This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult 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 Aug 2026
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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2026
CompletedFirst Posted
Study publicly available on registry
July 30, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
ExpectedJuly 30, 2026
July 1, 2026
Same day
July 24, 2026
July 24, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Incidence of dose-limiting toxicity (DLT)
six month
Incidence and severity of adverse events (AEs)
six month
Serious adverse events (SAEs) .
six month
MTD
1 year
RP2D
1 year
Study Arms (1)
SHR-6914
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
- Presence of metastatic lesions confirmed by evaluable imaging examinations (per PCWG4, evaluable imaging examinations refer to examinations with definite lesion assessment criteria, including CT, MRI or bone scan).
- Has an ECOG PS 0-1.
- Has a life expectancy of ≥ 3 months.
- Has adequate organ function
You may not qualify if:
- With untreated local therapy (radiotherapy or surgery) or active central nervous system (CNS) tumor metastases. Participants with a history of leptomeningeal metastasis or current leptomeningeal metastasis.
- Patients with other malignant tumors within 5 years prior to the first study drug administration, excluding adequately treated basal cell carcinoma or squamous cell carcinoma.
- Those with uncontrolled tumor-related pain as judged by the investigator, who require analgesic medication.
- Having severe cardiovascular and cerebrovascular diseases
- Suffering from active severe digestive system diseases
- History of prior interstitial pneumonia
- Has active infection requiring systemic treatment.
- Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE grade ≤1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, 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
July 24, 2026
First Posted
July 30, 2026
Study Start
August 1, 2026
Primary Completion
August 1, 2026
Study Completion (Estimated)
August 1, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07