Clinical trial · Interventional
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
NCT07735377CI-TRIAL-00122930recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-6914 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SHR-6914
- interventionNames
- Drug: SHR-6914
Primary outcomes (5)
- measure
- Incidence of dose-limiting toxicity (DLT)
- timeFrame
- six month
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- six month
- measure
- Serious adverse events (SAEs) .
- timeFrame
- six month
- measure
- MTD
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.