Can a Two-Pronged attack shrink Hard-to-Treat cancers?

NCT ID NCT06022757

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 23, 2026 · Last updated Jul 24, 2026 · Updated 1 time

Summary

This trial tests whether an experimental drug called XNW5004, which blocks a protein that helps cancer grow, can boost the effects of the immunotherapy pembrolizumab (Keytruda) in people with advanced solid tumors that have stopped responding to standard treatments. The study includes several cancer types, such as head and neck, lung, prostate, and bladder cancers. Researchers aim to find the best dose and see if the combination can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental EZH2 inhibitor called XNW5004 combined with the immunotherapy drug pembrolizumab (Keytruda)
What this could lead to
If it works, this combination could offer a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early-phase trial with only 12 participants, so results may not apply broadly. The combination may cause significant side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

12 people

The number who actually took part.

Started

Sep 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Cohort 3: 1. 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. 2. 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). 3. Disease progression at screening. 4. Continuous luteinizing hormone-releasing agonist (LHRHa) or antagonist therapy (drug castration) or prior bilateral orchiectomy (surgical castration). 5. 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. 1. Cohort 5a: Previous use of and resistant to EGFR inhibitors and failed standard treatment. 2. 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: 1. Has received at least 2 doses of approved PD-1/PD-L1 inhibitors. 2. 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. Exclusion Criteria: * Cohort-specific exclusion criteria: 1. 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. 2. 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. * Any previous treatment targeting T-cell co-stimulation or checkpoint pathways. 3. 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Carcinoma are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center (SYSUCC)

    Guangzhou, Guodong Province, 528404, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.