Not yet recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-6914.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug SHR-6914
SHR-6914
Primary outcome measures
- Incidence of dose-limiting toxicity (DLT) [Time frame: six month]
- Incidence and severity of adverse events (AEs) [Time frame: six month]
- Serious adverse events (SAEs) . [Time frame: six month]
- MTD [Time frame: 1 year]
- RP2D [Time frame: 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT07735377 · SHR-6914-101