RecruitingPhase 1Phase 2NCT06022757

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

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


Sponsor

Evopoint Biosciences Inc.

Enrollment

204 participants

Start Date

Sep 20, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a new tablet drug called XNW5004 combined with pembrolizumab (a standard immunotherapy) in people with advanced solid tumors — including head and neck cancer, bladder cancer, prostate cancer, lung cancer, and others — whose cancer has stopped responding to prior standard treatments including immunotherapy. **You may be eligible if...** - You are 18 or older with an advanced solid tumor from the eligible cancer types (e.g., head/neck cancer, bladder cancer, NSCLC, SCLC, prostate cancer, or others) - Your cancer has progressed after prior standard therapy, including PD-1/PD-L1 immunotherapy for most cohorts - You have adequate organ function and measurable disease **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have active autoimmune disease requiring systemic treatment - You are pregnant or breastfeeding - You have had a recent serious cardiovascular event - You have active hepatitis B or C or uncontrolled HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXNW5004

XNW5004 an EZH2 inhibitor, BID, administered in continuous

DRUGKEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection

KEYTRUDA® (pembrolizumab) a programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks.


Locations(1)

Sun Yat-sen University Cancer Center (SYSUCC)

Guangzhou, Guodong Province, China

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NCT06022757


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