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NCT Number: NCT07735377

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location contact

Yanxia Shi

PRINCIPAL_INVESTIGATOR

Yonghong Li

PRINCIPAL_INVESTIGATOR

Zhuowei Liu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR-6914

Drug

SHR-6914

Primary outcomes

  1. Incidence of dose-limiting toxicity (DLT)

    Time frame: six month

  2. Incidence and severity of adverse events (AEs)

    Time frame: six month

  3. Serious adverse events (SAEs) .

    Time frame: six month

  4. MTD

    Time frame: 1 year

  5. RP2D

    Time frame: 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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