CarcinomaPhase 1/2NCT06022757
Study of XNW5004 Tablet in Combination With KEYTRUDA® (Pembrolizumab) in Subjects With Advanced Solid Tumors Who Failed Standard Treatments (KEYNOTE F19)
A Phase 1/2 study testing XNW5004 and KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection in people with Carcinoma and Squamous Cell Carcinoma of Head and Neck, run by Evopoint Biosciences Inc. at 1 site in China.
Trial 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) . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma
- What is being tested?
- XNW5004 and KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2023to 13 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Cohort 3:
- Metastatic castration-resistant prostate adenocarcinoma with histological or cytological evidence of disease progression except neuroendocrine or small cell carcinoma; Imaging examination (CT/MRI/ bone scan) confirmed metastatic lesions.
- Failed previous standard treatments, and at least received one second-generation anti-androgen drug treatment (including but not limited to abiraterone acetate, enzalutamide or apalutamide).
- Disease progression at screening.
- Continuous luteinizing hormone-releasing agonist (LHRHa) or antagonist therapy (drug castration) or prior bilateral orchiectomy (surgical castration).
- Testosterone at screening was at castration level.
- Cohort 4: Subjects with histologically or cytologically confirmed extensive-stage small cell lung cancer with disease progression after first-line standard therapy.
- Cohort 5: Subjects with histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer.
- Cohort 5a: Previous use of and resistant to EGFR inhibitors and failed standard treatment.
- Cohort 5b: No driver gene mutations identified and failed standard therapy containing PD-1/PD-L1 inhibitors.
- Cohort 6: Subjects with advanced solid tumors other than those described in the above cohorts, and failed standard therapy. For recurrent or metastatic cervical cancer, it should be histologically or cytologically confirmed as squamous cell carcinoma, progressed after systematic standard treatment, and is not suitable for radical therapy .
- For patients who have progressed on treatment with PD-1/PD-L1 inhibitors administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, PD-1/PD-L1 inhibitor treatment progression is defined by meeting all of the following criteria:
- Has received at least 2 doses of approved PD-1/PD-L1 inhibitors.
- Documented objective radiographic progression following initiation of treatment with a PD-1/PD-L1 inhibitor. Subjects should not be enrolled if they are suspected of permanent withdrawal due to pseudo-progression after previous PD-1/PD-L1 inhibitor treatment.
- To the extent possible, provide formalin-fixed, paraffin-embedded (FFPE) tumor tissue section (previously archived or fresh) samples and blood samples that meet the detection requirements for exploratory studies.
- Life expectancy ≥ 3 months.
- At least one measurable lesion according to RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
- Have adequate organ function.
- Females of child-bearing potential and males who use adequate birth control through 6 months post last dose.
Who cannot join
- Cohort-specific exclusion criteria:
- 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)
- Severe bone injury caused by tumor bone metastasis, including severe, uncontrolled bone pain as judged by the investigator, bone fractures or spinal cord compression at critical parts of the body that occurred in the last 6 months or are expected to occur in a near future.
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- Any previous treatment targeting T-cell co-stimulation or checkpoint pathways.
- Cohort 5 (non-small cell lung cancer)
- Any previous treatment targeting T-cell co-stimulation or checkpoint pathways other than PD-1 / PD-L1 inhibitors.
- 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.)
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.
- Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s) (including but not limited to tazemetostat).
- Subjects known to be allergic to the study drug or its active ingredients or excipients, or subjects with prior severe hypersensitivity to other monoclonal antibody therapy in the past.
- Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose.
- Subjects who participated in any other clinical trial of anti-tumor therapy within 28 days before the first dosing, and the last dose of other anti-tumor trial drug is within 28 days prior to the first administration of study drug in this trial.
- Subjects who underwent major surgery within 4 weeks prior to the start of the study treatment, or who are scheduled to undergo a major surgery during the study period (procedures such as puncture or lymph node biopsy is allowed).
- Subjects who have an allogenic bone marrow transplantation or solid organ transplantation.
- Subjects who have diseases requiring systemic therapy with corticosteroids (> 10 mg of prednisone or equivalent dose of other glucocorticoids) or other immunosuppressive medications within 14 days prior to the study drug administration. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy is allowed with a dose of ≤ 10 mg of prednisone or equivalent doses of other glucocorticoids.
- Subjects who took moderate to strong CYP3A4 inhibitor/inducer medications within 14 days prior to the first dose of study drug.
- Subjects who have received live vaccines (including attenuated live vaccines) within 28 days prior to the administration of study drug. Inactivated vaccines are permitted.
- Subjects who experienced toxicity events during previous anti-tumor treatment and the toxicity has not resolved (toxicity has not resolved means the severity of the toxicity events has not been graded as ≤ level 1 according to National Cancer Institute- Common Terminology Criteria for Adverse Events [NCI-CTCAE] 5.0). Other toxicities that the investigator does not think it will affect the safety assessment of the subject (such as hair loss, etc.) will be allowed.
- Subjects who have a history of other malignancies within 3 years prior to enrollment and do not meet the criteria for clinical cure. This exclusion criterion does not apply to skin basal cell carcinoma or squamous cell carcinoma with local treatment methods available and has been cured, superficial bladder cancer, primary cervical carcinoma in situ, intraductal breast carcinoma in situ, and papillary thyroid carcinoma.
- Subjects who have symptoms of active central nervous system metastases. However, subjects with stable brain parenchymal metastases can be enrolled.
- Subjects who have active autoimmune disease that has received systemic treatment in the past 2 years (i.e., taking disease control medications, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered to be systemic treatments.
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease. Has had a history of radiation pneumonitis.
- Subjects who have serious psychiatric illness and are unable to cooperate in completing the clinical study.
- Has an active infection requiring systemic therapy.
- Has tuberculosis that is being treated.
- Subjects who have known history of human immunodeficiency virus (HIV) or Anti- Treponema Pallidum test (anti-TP) positive.
- Known acute or chronic active hepatitis B (HBsAg positive or HBcAb positive, and HBV DNA ≥ 200 IU/mL or ≥ 10^3 copies/mL) or acute or chronic active hepatitis C (HCV antibody positive and positive for HCV RNA test).
- Subjects who have history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell lymphoblastic leukemia (T-ALL).
- Subjects who have history of any myeloid malignancies including myelodysplastic syndrome (MDS), or subjects who have abnormal test results related to MDS or myeloproliferative neoplasm (MPN).
- Women during pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guodong Province, 528404
About this study
Official title: 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)
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
- Carcinoma, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Prostate Cancer, Small-cell Lung Cancer, Non-small Cell Lung Cancer
- Being tested
- XNW5004, KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection
- Keywords
- XNW5004, EZH2 inhibitor, KEYTRUDA® (pembrolizumab), immune checkpoint inhibitors
- Medical subject headings
- Carcinoma, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Transitional Cell, Prostatic Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XNW5004Drug
XNW5004 an EZH2 inhibitor, BID, administered in continuous
KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionDrug
KEYTRUDA® (pembrolizumab) a programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and Safety of XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase Ib) | Experimental | Dose escalation and safety with repeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. Receives: Drug: XNW5004; Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection |
| HNSCC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 1) | Experimental | Repeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with head and neck squamous cell carcinoma (including nasopharyngeal carcinoma), urothelial carcinoma, metastatic castration-resistant prostate adenocarcinoma, small cell lung cancer, non-small cell lung cancer, other solid tumor (including cervical cancer) Receives: Drug: XNW5004; Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection |
| Urothelial carcinoma：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 2) | Experimental | Repeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with urothelial carcinoma Receives: Drug: XNW5004; Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection |
| mCRPC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 3) | Experimental | Repeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with metastatic castration-resistant prostate adenocarcinoma Receives: Drug: XNW5004; Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection |
| Small cell lung cancer：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 4) | Experimental | Repeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with small cell lung cancer Receives: Drug: XNW5004; Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection |
| non-small cell lung cancer:XNW5004 in combination with KEYTRUDA®(pembrolizumab)(PhaseII-cohort5) | Experimental | Repeated administrations of XNW5004 in combination with infusions of KEYTRUDA®(pembrolizumab) in patients with non-small cell long cancer Receives: Drug: XNW5004; Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection |
| ：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 6) | Experimental | Repeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with other solid tumor (including cervical cancer) Receives: Drug: XNW5004; Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D) of XNW5004 in Combination With KEYTRUDA® (pembrolizumab) (Phase 1b Only)
Recommended Phase 2 dose (RP2D) of XNW5004 as administered orally twice daily (BID), continuously in 21-day cycles, in combination with KEYTRUDA® (pembrolizumab) in subjects with advanced solid tumors by safety data, pharmacokinetic data, pharmacodynamic data and efficacy data
Measured: The first 21-day cycle of therapy
Objective Response Rate (ORR) (Phase 2)
ORR is defined as the proportion of subjects who have a confirmed complete response (CR) or a partial response (PR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
Measured: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
Secondary outcomes (6)
ORR(Phase 1b)
ORR is defined as the proportion of subjects who have a confirmed CR or a PR per RECIST 1.1.
Measured: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
Duration of response (DOR)(Phase 1b and Phase 2)
DOR is defined defined as the length of time from the date of first confirmed CR or PR per RECIST 1.1(whichever status is recorded first) to the date of first evaluation of progressive disease, or death due to any reasons.
Measured: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
Progression free survival (PFS) (Phase 1b and Phase 2)
PFS is defined as the the length of time from the date of first administration of the study drug until the date of disease progression or death.
Measured: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
Percentage of Participants With Adverse Events（AE） (Phase 2）
An AE is any untoward medical occurrence in a clinical investigation subject administered a study drug and an AE can therefore be any symptom, disease or an abnormal laboratory finding, whether or not related to the investigational product. Severity of AEs is assessed according to Common Terminology Criteria for Adverse Events Version (CTCAE 5.0).
Measured: Up to 2.5 years
Maximum Concentration (Cmax) of XNW5004 in Solid Tumor Participants (Phase 1 and Phase 2）
Blood samples were collected at specified intervals for the determination of Cmax.
Measured: Cycle 1 (each cycle is 21 days)
the area under the plasma concentration-time curve at steady state (AUCss) in Solid Tumor Participants (Phase 1 and Phase 2）
Blood samples were collected at specified intervals for the determination of AUCss.
Measured: Cycle 1 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start20 Sep 2023
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Why it stopped: Strategic decision by Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evopoint Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Li Zhang, M.D., Principal investigator, botanic physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022757
- Sponsor's protocol ID
- XNW5004-Ib/II-04
- Other IDs
- KEYNOTE F19, MK-3475-F19
- Status last verified
- Jun 2026
- First submitted
- 17 Aug 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06022757
- Acronym / sponsor ID
- XNW5004-Ib/II-04
- Conditions
- Carcinoma, Squamous Cell Carcinoma of Head and Neck, Urothelial Carcinoma, Prostate Cancer, Small-cell Lung Cancer, Non-small Cell Lung Cancer
- Keywords
- XNW5004, EZH2 inhibitor, KEYTRUDA® (pembrolizumab), immune checkpoint inhibitors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision by Sponsor.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Evopoint Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and Safety of XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase Ib) | Experimental | Drug: XNW5004, Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionDose escalation and safety with repeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. |
| HNSCC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 1) | Experimental | Drug: XNW5004, Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionRepeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with head and neck squamous cell carcinoma (including nasopharyngeal carcinoma), urothelial carcinoma, metastatic castration-resistant prostate adenocarcinoma, small cell lung cancer, non-small cell lung cancer, other solid tumor (including cervical cancer) |
| Urothelial carcinoma：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 2) | Experimental | Drug: XNW5004, Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionRepeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with urothelial carcinoma |
| mCRPC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 3) | Experimental | Drug: XNW5004, Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionRepeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with metastatic castration-resistant prostate adenocarcinoma |
| Small cell lung cancer：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 4) | Experimental | Drug: XNW5004, Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionRepeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with small cell lung cancer |
| non-small cell lung cancer:XNW5004 in combination with KEYTRUDA®(pembrolizumab)(PhaseII-cohort5) | Experimental | Drug: XNW5004, Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionRepeated administrations of XNW5004 in combination with infusions of KEYTRUDA®(pembrolizumab) in patients with non-small cell long cancer |
| ：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 6) | Experimental | Drug: XNW5004, Drug: KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionRepeated administrations of XNW5004 in combination with infusions of KEYTRUDA® (pembrolizumab) in patients with other solid tumor (including cervical cancer) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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:
- For patients who have progressed on treatment with PD-1/PD-L1 inhibitors administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies, PD-1/PD-L1 inhibitor treatment progression is defined by meeting all of the following criteria:
Key exclusion criteria (33 listed)
- Cohort-specific exclusion criteria:
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher irAE.
- Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s) (including but not limited to tazemetostat).
- Subjects known to be allergic to the study drug or its active ingredients or excipients, or subjects with prior severe hypersensitivity to other monoclonal antibody therapy in the past.
- Subjects who received anti-tumor therapies including chemotherapy, immunotherapy, radical radiotherapy, major surgery, targeting therapy and other anti-tumor therapies within 4 weeks or 5 half-lives of the drug (whichever is shorter) before the first dose; or received palliative radiotherapy within 2 weeks before the first dose.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XNW5004XNW5004 an EZH2 inhibitor, BID, administered in continuous | Drug | Dose escalation and Safety of XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase Ib), HNSCC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 1), Small cell lung cancer：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 4), Urothelial carcinoma：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 2), mCRPC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 3), non-small cell lung cancer:XNW5004 in combination with KEYTRUDA®(pembrolizumab)(PhaseII-cohort5), ：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 6) |
| KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for InjectionKEYTRUDA® (pembrolizumab) a programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks. | Drug | Dose escalation and Safety of XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase Ib), HNSCC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 1), Small cell lung cancer：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 4), Urothelial carcinoma：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 2), mCRPC：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 3), non-small cell lung cancer:XNW5004 in combination with KEYTRUDA®(pembrolizumab)(PhaseII-cohort5), ：XNW5004 in combination with KEYTRUDA® (pembrolizumab) (Phase II - cohort 6) |
Primary outcome
Recommended Phase 2 Dose (RP2D) of XNW5004 in Combination With KEYTRUDA® (pembrolizumab) (Phase 1b Only)
Time frame: The first 21-day cycle of therapy
Recommended Phase 2 dose (RP2D) of XNW5004 as administered orally twice daily (BID), continuously in 21-day cycles, in combination with KEYTRUDA® (pembrolizumab) in subjects with advanced solid tumors by safety data, pharmacokinetic data, pharmacodynamic data and efficacy data
Objective Response Rate (ORR) (Phase 2)
Time frame: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
ORR is defined as the proportion of subjects who have a confirmed complete response (CR) or a partial response (PR) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
6 secondary outcomes
ORR(Phase 1b)
Time frame: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
Duration of response (DOR)(Phase 1b and Phase 2)
Time frame: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
Progression free survival (PFS) (Phase 1b and Phase 2)
Time frame: Radiologic tumor assessments performed at baseline(within 28 days before start of study treatment)and every 9 weeks in the first 54 weeks (including the 54th week) after the first drug administration then every 12 weeks thereafter until confirmed disease
Percentage of Participants With Adverse Events（AE） (Phase 2）
Time frame: Up to 2.5 years
Maximum Concentration (Cmax) of XNW5004 in Solid Tumor Participants (Phase 1 and Phase 2）
Time frame: Cycle 1 (each cycle is 21 days)
the area under the plasma concentration-time curve at steady state (AUCss) in Solid Tumor Participants (Phase 1 and Phase 2）
Time frame: Cycle 1 (each cycle is 21 days)
Results and safety
The study was stopped early (reason given: Strategic decision by Sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Zhang, M.D. principal investigator
botanic physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XNW5004 and KEYTRUDA® (pembrolizumab) 25 mg/mL Solution for Injection in people with Carcinoma and Squamous Cell Carcinoma of Head and Neck, run by Evopoint Biosciences Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic decision by Sponsor.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) of XNW5004 in Combination With KEYTRUDA® (pembrolizumab) (Phase 1b Only) (time frame: The first 21-day cycle of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.