A Multicenter, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-6914 Injection in... | NCT07735377

NCT07735377

Overview

NCT ID: NCT07735377
Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.INDUSTRY
Official Title: 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
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.
Conditions: Prostate Cancer
Interventions: SHR-6914

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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 0-1.

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