NCT07735377RecruitingPhase 1
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
Suzhou Suncadia Biopharmaceuticals Co., Ltd.2 sites in 1 country118 target enrollmentStarted: August 26, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Incidence of dose-limiting toxicity (DLT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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-
- •Has a life expectancy of ≥ 3 months.
- •Has adequate organ function
Exclusion Criteria
- •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
Arms & Interventions
SHR-6914
Experimental
Intervention: SHR-6914 (Drug)
Outcomes
Primary Outcomes
Incidence of dose-limiting toxicity (DLT)
Time Frame: six month
Incidence and severity of adverse events (AEs)
Time Frame: six month
Serious adverse events (SAEs) .
Time Frame: six month
MTD
Time Frame: 1 year
RP2D
Time Frame: 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
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