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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07735377

Enrollment

118

Registered

2026-07-30

Start date

2026-08-26

Completion date

2028-08-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGSHR-6914

SHR-6914

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

China

Contacts

CONTACTYue Cheng

yue.cheng.yc50@hengrui.com0518-82342973

CONTACTQi Zhang

qi.zhang@hengrui.com021-60453139

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026