NCT06022757 Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
| NCT ID | NCT06022757 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Evopoint Biosciences Inc. |
| Condition | Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2023-09-20 |
| Primary Completion | 2028-08 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
In this study, participants with different types of advanced solid tumors who failed standard treatments will be treated with XNW5004 in combination with KEYTRUDA® (pembrolizumab) .
Eligibility Criteria
Inclusion Criteria: * Sign informed consent form prior to the commencement of any research activity/procedure. * Age ≥ 18. * Cohort 3 (mCRPC cohort) is male-only, and no gender restrictions for other cohorts. * Subjects with advanced solid tumors who meet one of the following requirements can be enrolled in the study. No cohorts planned for the Phase Ib study, whereas the Phase II study is divided into 6 cohorts: * Cohort: 1 Histologically or cytologically confirmed recurrent or metastatic head and neck squamous cell carcinoma (including nasopharyngeal carcinoma),has progressed after treatment with a standard regimen containing PD-1/PD-L1 inhibitors. * Cohort 2: Histologically confirmed advanced urothelial carcinoma (including urothelial carcinoma of bladder, renal pelvis, ureter, and urethral origin) that is not suitable for surgical treatment and has progressed after treatment with a standard regimen containing PD-1/PD-L1 inhibitors. * Cohort 3: 1. Metastatic castration-resistant pro