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

Recruiting · NCT07735377 · Interventional (participants receive a specific treatment) · Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Interventions studied

SHR-6914

This is a phase 1 study to assess the safety and tolerability of SHR-6914 as monotherapy therapy in adult subjects with prostate cancer.

Age range

18 Years to 80 Years

Sex

Male

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 1

Study type

Interventional (participants receive a specific treatment)

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

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

1 location listed.