Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)

ConditionsCarcinoma Squamous Cell Carcinoma of Head and Neck Urothelial Carcinoma Prostate Cancer Small-cell Lung Cancer Non-small Cell Lung Cancer Cervical Cancer Other Solid Tumors

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorEvopoint Biosciences Inc.

About this trial

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

Qualifiers

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.

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.

Disqualifiers

Cohort 1 (head and neck squamous cell carcinoma cohort)

Neuroendocrine carcinoma and small cell carcinoma.

Salivary adenocarcinoma or other non squamous cell carcinoma (such as adenocarcinoma, sarcoma or mixed carcinoma) confirmed by histology or cytology, and metastatic squamous cell carcinoma with unknown primary origin. This exclusion criterion is not applicable to nasopharyngeal cancer.

Cohort 3 (mCRPC)

Trial design

Treatments tested in this trial

XNW5004
KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection

Treatment groups

204 Participants

are divided into 7 treatment groups

Treatment groups

See each treatment group below.

Sponsors and collaborators

Evopoint Biosciences Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov