OncoMatch/Clinical Trials/NCT06022757
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
Is NCT06022757 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including XNW5004 and KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for for carcinoma.
Treatment: XNW5004 · KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for — 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) .
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Urothelial Carcinoma
Prostate Cancer
Non-Small Cell Lung Carcinoma
Cervical Cancer
Tumor Agnostic
Biomarker criteria
Required: EGFR wild-type
Cohort 5b: No driver gene mutations identified and failed standard therapy containing PD-1/PD-L1 inhibitors
Required: ALK rearrangement
Combined with other targetable driver mutations either alone or in addition to EGFR, including but not limited to: ALK gene rearrangement, ROS1 mutations, BRAFV600E mutation, etc. (For cohort 5a only.)
Required: ROS1 mutation
Combined with other targetable driver mutations either alone or in addition to EGFR, including but not limited to: ALK gene rearrangement, ROS1 mutations, BRAFV600E mutation, etc. (For cohort 5a only.)
Required: BRAF V600E
Combined with other targetable driver mutations either alone or in addition to EGFR, including but not limited to: ALK gene rearrangement, ROS1 mutations, BRAFV600E mutation, etc. (For cohort 5a only.)
Allowed: EGFR mutation
Cohort 5a: Previous use of and resistant to EGFR inhibitors and failed standard treatment
Disease stage
Required: Stage III, IV
locally advanced or metastatic; recurrent or metastatic; extensive-stage; at least one measurable lesion according to RECIST 1.1
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: PD-1/PD-L1 inhibitor — progressed after treatment with a standard regimen containing PD-1/PD-L1 inhibitors
progressed after treatment with a standard regimen containing PD-1/PD-L1 inhibitors
Must have received: second-generation antiandrogen (abiraterone acetate, enzalutamide, apalutamide) — Cohort 3 (mCRPC)
at least received one second-generation anti-androgen drug treatment (including but not limited to abiraterone acetate, enzalutamide or apalutamide)
Must have received: EGFR tyrosine kinase inhibitor — Cohort 5a
Previous use of and resistant to EGFR inhibitors and failed standard treatment
Cannot have received: EZH2 inhibitor (tazemetostat)
Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s) (including but not limited to tazemetostat)
Cannot have received: T-cell co-stimulation or checkpoint pathway inhibitor (other than PD-1/PD-L1) (CTLA-4, OX40, CD137)
Any previous treatment targeting T-cell co-stimulation or checkpoint pathways
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Have adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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