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
This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.
Eligibility
Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Histologically or cytologically confirmed prostate adenocarcinoma without neuroendocrine or small cell features
2. 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).
3. Has an ECOG PS 0-1.
4. Has a life expectancy of ≥ 3 months.
5. Has adequate organ function
Exclusion Criteria:
1. 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.
2. 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.
3. Those with uncontrolled tumor-related pain as judged by the investigator, who require analgesic medication.
4. Having severe cardiovascular and cerebrovascular diseases
5. Suffering from active severe digestive system diseases
6. History of prior interstitial pneumonia
7. Has active infection requiring systemic treatment.
8. Adverse reactions from prior anti-tumor therapy have not recovered to CTCAE grade ≤1
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Recruiting
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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