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

Official record

Identifier

NCT07735377

Recruiting locations

country

China

Interventions studied

SHR-6914

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Target enrolment

118 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Not yet recruiting

First posted

Jul 30, 2026

Last updated on the registry

Jul 30, 2026

Age

18 Years – 80 Years

Sex

MALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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

Indexed under

Prostate Cancer