Actively Recruiting
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
Led by Evopoint Biosciences Inc. · Updated on 2024-02-23
204
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
Sponsors
E
Evopoint Biosciences Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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) .
CONDITIONS
Official Title
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form before any study procedures
- Age 18 years or older
- Male only for metastatic castration-resistant prostate cancer cohort; no gender restrictions for other cohorts
- Diagnosis of advanced solid tumor including head and neck squamous cell carcinoma, urothelial carcinoma, metastatic castration-resistant prostate adenocarcinoma, extensive-stage small cell lung cancer, non-small cell lung cancer, cervical cancer, or other solid tumors with progression after standard treatments
- For prostate cancer cohort: must have disease progression and prior treatment with at least one second-generation anti-androgen drug
- Disease progression after treatment with PD-1/PD-L1 inhibitors, having received at least two doses and documented radiographic progression
- Provide tumor tissue and blood samples for exploratory studies
- Life expectancy of at least 3 months
- At least one measurable lesion as per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function
- Females of childbearing potential and males must use effective birth control during study and for 6 months after last dose
You will not qualify if you...
- Excluded histologies in head and neck cohort: neuroendocrine carcinoma, small cell carcinoma, salivary adenocarcinoma, non-squamous cell carcinoma except nasopharyngeal carcinoma
- Severe bone injury or uncontrolled bone pain for prostate cancer cohort
- Prior treatment targeting T-cell co-stimulation or checkpoint pathways (other than PD-1/PD-L1 inhibitors in specified cohorts)
- Presence of other targetable driver mutations in non-small cell lung cancer cohort
- Prior treatment discontinuation due to Grade 3 or higher immune-related adverse events
- Prior exposure to EZH2 or EZH1/2 inhibitors
- Allergic to study drugs or severe hypersensitivity to monoclonal antibodies
- Recent anti-tumor therapies, major surgery, or participation in other anti-tumor clinical trials within specified time frames
- History of allogenic bone marrow or solid organ transplantation
- Use of systemic corticosteroids or immunosuppressive medications within 14 days prior to study drug
- Use of moderate to strong CYP3A4 inhibitors or inducers within 14 days prior to first dose
- Recent live vaccinations within 28 days prior to study drug
- Unresolved toxicity from previous anti-tumor treatments above grade 1
- History of other malignancies within 3 years except certain treated cancers
- Active central nervous system metastases except stable brain metastases
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or presence of pneumonitis or interstitial lung disease requiring steroids
- Serious psychiatric illness impeding study participation
- Active infection requiring systemic therapy
- Active tuberculosis
- Known HIV or positive anti-Treponema Pallidum test
- Active hepatitis B or C infection
- History of T-cell lymphoblastic lymphoma or leukemia
- History or abnormal tests related to myeloid malignancies
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guodong Province, China, 528404
Actively Recruiting
Research Team
L
Li Zhang, M.D.
CONTACT
H
Hongyun Zhao, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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