Soft Tissue SarcomaPhase 2NCT07917949
Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma
A Phase 2 study testing zemetostat combined with anlotinib in people with Soft Tissue Sarcoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This is a single-center, single-arm, prospective, Phase II clinical study designed to evaluate the efficacy and safety of zemetostat combined with anlotinib in patients with head-and-neck soft-tissue sarcoma featuring SWI/SNF complex deficiency whose disease has progressed following standard-of-care therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- zemetostat combined with anlotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2026to 10 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged 18-75 years, regardless of gender. 2. Patients with histopathologically confirmed head-and-neck soft-tissue sarcoma that is recurrent/metastatic after surgery with no curative-intent treatment (surgery/radiotherapy) options, or locally advanced unresectable disease; with measurable lesions (≥10 mm on spiral CT scan, meeting RECIST 1.1 criteria).
- 3. Have previously received at least one cycle of doxorubicin-containing chemotherapy, with radiologically confirmed disease progression or judged by the investigator to derive no further clinical benefit from prior therapy. Prior chemotherapy must have been completed at least 4 weeks before the first study drug administration, and all treatment-related toxicities must have resolved to baseline or to Grade 1 or lower per CTCAE Version 5.0.
- 4. Malignant tumors with immunohistochemically-verified deficiency of the SWI/SNF (BAF) complex (including ARID1A, ARID1B, SMARCA2 (BRM), SMARCA4 (BRG1), SMARCB1 (INI1), etc.).
- 5. Accessible evaluable tumor tissue (paraffin-embedded specimen obtained within the past 2 years or fresh tumor tissue).
- 6. ECOG performance status of 0 or 1. 7. Expected survival ≥12 weeks. 8. Adequate major organ function within 2 weeks prior to treatment initiation, as defined below: i. Bone marrow: hemoglobin ≥100 g/L without transfusion or colony-stimulating factor support; white blood cell count ≥4.0 × 10⁹/L or absolute neutrophil count ≥2.0 × 10⁹/L; platelet count ≥100 × 10⁹/L.
- Liver: total serum bilirubin ≤1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN.
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- Kidney: serum creatinine <1.5 × ULN or creatinine clearance ≥60 mL/min; blood urea nitrogen ≤200 mg/L.
- Urine protein: negative on dipstick; if dipstick shows 1+ protein, 24-hour total urinary protein must be <500 mg.
- Blood glucose: within normal range; or patients with diabetes on stable anti-diabetic therapy with well-controlled glycemia.
- Cardiac function: no myocardial infarction within 1 year; no unstable angina; no symptomatic severe arrhythmia; no cardiac insufficiency.
- 9. Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to the first study drug dose. Fertile men and women with child-bearing potential must use highly effective contraceptive measures throughout the study (e.g., oral contraceptives, intrauterine device, sexual abstinence, or barrier contraception combined with spermicide), and continue contraception for 12 months after treatment completion.
- 10. Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and are willing to complete follow-up assessments.
- 11. Patients for whom the investigator judges study treatment may confer clinical benefit.
Who cannot join
- 1. Patients previously treated with anlotinib or EZH1/2 / EZH2 inhibitors. 2. Re-irradiation to the head-and-neck region (including cervical, supraclavicular and infraclavicular lymph nodes) within 6 months prior to enrollment.
- 3. Tumor encasement, invasion or infiltration of major blood vessels; tumor invasion into skin or mucosal cavities; or ulcerated/bleeding tumor lesions.
- 4. Known hypersensitivity to anlotinib, zemetostat, or any of their excipients. 5. Concurrent use of known moderate- or strong-inducers / inhibitors of CYP3A4 / CYP3A5, or P-gp inhibitors.
- 6. Uncontrolled hypertension despite anti-hypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- 7. Any condition impairing oral drug ingestion, or any condition altering drug disposition (absorption, distribution, metabolism or excretion) in vivo.
- 8. Coagulopathy (INR > 2.0, PT > 16 s); bleeding diathesis; or receiving thrombolytic or anticoagulant therapy. Prophylactic low-dose aspirin and low-molecular-weight heparin are permitted.
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- 9. Clinically significant bleeding events or definite bleeding diathesis within 3 months before enrollment, such as hemoptysis ≥2.5 mL/day, gastrointestinal hemorrhage, high-risk esophageal-gastric varices, hemorrhagic gastric ulcer, vasculitis, etc. If baseline fecal occult blood is positive, repeat testing is required. If persistently positive, gastroscopy shall be performed. Patients with severe esophageal-gastric varices identified on gastroscopy are excluded (exception: patients who underwent gastroscopy within the preceding 3 months to rule out such findings).
- 10. Known inherited or acquired bleeding or thrombotic predisposition (e.g., hemophilia, coagulation disorders, thrombocytopenia).
- 11. Receiving concurrent anti-neoplastic therapy. 12. Participation in other investigational drug / therapeutic clinical trials within 4 weeks before the first study drug dose.
- 13. Positive human immunodeficiency virus (HIV) antibody or Treponema pallidum antibody.
- 14. Active hepatitis B or hepatitis C infection:
- For subjects positive for HBsAg or HBcAb: HBV-DNA level above the upper limit of normal.
- For subjects positive for HCV antibody: HCV-RNA level above the upper limit of normal.
- 15. Symptomatic large-volume pleural effusion or ascites requiring clinical intervention.
- 16. Active pulmonary disease (interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or history of active pulmonary tuberculosis.
- 17. Any uncontrolled clinical medical conditions, including but not limited to:
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- Persistent or active severe infection;
- Poorly controlled diabetes mellitus;
- Cardiac disease (New York Heart Association Grade III/IV congestive heart failure or cardiac conduction block).
- 18. Any of the following events occurring within 6 months prior to first study drug administration: deep-vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmia or angina pectoris; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism.
- 19. Prior stem-cell transplantation or solid-organ transplantation. 20. History of untreatable substance abuse involving psychotropic agents, or history of psychiatric disorders.
- 21. Other severe, acute or chronic medical illnesses or laboratory abnormalities that, in the investigator's opinion, may increase study-related risks or confound interpretation of study results.
- 22. Poor compliance as judged by the investigator, or other conditions rendering the subject unsuitable for study participation.
- 23. History of other malignant malignancies within the past 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Guoxin Ren, M.D., 13916948812, renguoxincn@sina.com
About this study
Official title: A Single-Arm, Prospective, Phase II Clinical Study of Zemetostat Combined With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma With SWI/SNF Complex Deficiency After Failure of Standard-of-Care Therapy
This is a single-center, single-arm, prospective, Phase II clinical study designed to evaluate the efficacy and safety of zemetostat combined with anlotinib in patients with head-and-neck soft-tissue sarcoma featuring SWI/SNF complex deficiency whose disease has progressed following standard-of-care therapy. Enrolled patients receive zemetostat plus anlotinib until discontinuation criteria are met. The specific dosing regimen is as follows: zemetostat 350 mg orally twice daily (bid po). The recommended dose of anlotinib is 12 mg once daily for 14 consecutive days, followed by a 7-day drug-free interval (2/1 schedule), constituting a 21-day treatment cycle. Doses should be taken at approximately the same time each day. If a patient vomits or misses a dose, no supplemental dose should be administered on that day; the subsequent scheduled dose should be taken as usual.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- zemetostat combined with anlotinib
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zemetostat combined with anlotinibDrug
Enrolled patients receive zemetostat plus anlotinib until discontinuation criteria are met. The specific dosing regimen is as follows: zemetostat 350 mg orally twice daily (bid po). The recommended dose of anlotinib is 12 mg once daily for 14 consecutive days, followed by a 7-day drug-free interval (2/1 schedule), constituting a 21-day treatment cycle. Doses should be taken at approximately the same time each day. If a patient vomits or misses a dose, no supplemental dose should be administered on that day; the subsequent scheduled dose should be taken as usual.
| Study group | Role | What they receive |
|---|---|---|
| zemetostat combined with anlotinib | Experimental | Enrolled patients receive zemetostat plus anlotinib until discontinuation criteria are met. The specific dosing regimen is as follows: zemetostat 350 mg orally twice daily (bid po). The recommended dose of anlotinib is 12 mg once daily for 14 consecutive days, followed by a 7-day drug-free interval (2/1 schedule), constituting a 21-day treatment cycle. Doses should be taken at approximately the same time each day. If a patient vomits or misses a dose, no supplemental dose should be administered on that day; the subsequent scheduled dose should be taken as usual. Receives: Drug: zemetostat combined with anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
PFS was defined as the time from enrollment to the first documented PD per RECIST 1.1, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD
Measured: 12 months
Secondary outcomes (3)
objective response rate
ORR was defined as the percentage of participants in the analysis population who have a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Measured: 12 months
overall survival
OS was defined as the time from enrollment to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Measured: 12 months
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants that experienced at least one AE was reported for each treatment arm.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start10 Nov 2026 (estimated)
- Primary completion10 Nov 2028 (estimated)
- Study completion10 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- zemetostat plus anlotinib
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ren guoxin, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Yue He, M.D., Principal investigator, the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917949
- Sponsor's protocol ID
- SH9H-2026-T440-2
- Status last verified
- Oct 2026
- First submitted
- 31 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective, Phase II Clinical Study of Zemetostat Combined With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma With SWI/SNF Complex Deficiency After Failure of Standard-of-Care Therapy
- ClinicalTrials.gov ID
- NCT07917949
- Acronym / sponsor ID
- SH9H-2026-T440-2
- Conditions
- Soft Tissue Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 10 Nov 2028 (estimated)
- Study completion
- 10 Nov 2029 (estimated)
- First posted
- 5 Nov 2026 (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.
This is a single-center, single-arm, prospective, Phase II clinical study designed to evaluate the efficacy and safety of zemetostat combined with anlotinib in patients with head-and-neck soft-tissue sarcoma featuring SWI/SNF complex deficiency whose disease has progressed following standard-of-care therapy. Enrolled patients receive zemetostat plus anlotinib until discontinuation criteria are met. The specific dosing regimen is as follows: zemetostat 350 mg orally twice daily (bid po). The recommended dose of anlotinib is 12 mg once daily for 14 consecutive days, followed by a 7-day drug-free interval (2/1 schedule), constituting a 21-day treatment cycle. Doses should be taken at approximately the same time each day. If a patient vomits or misses a dose, no supplemental dose should be administered on that day; the subsequent scheduled dose should be taken as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- zemetostat plus anlotinib
| Arm | Type | Receives |
|---|---|---|
| zemetostat combined with anlotinib | Experimental | Drug: zemetostat combined with anlotinibEnrolled patients receive zemetostat plus anlotinib until discontinuation criteria are met. The specific dosing regimen is as follows: zemetostat 350 mg orally twice daily (bid po). The recommended dose of anlotinib is 12 mg once daily for 14 consecutive days, followed by a 7-day drug-free interval (2/1 schedule), constituting a 21-day treatment cycle. Doses should be taken at approximately the same time each day. If a patient vomits or misses a dose, no supplemental dose should be administered on that day; the subsequent scheduled dose should be taken as usual. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Aged 18-75 years, regardless of gender. 2. Patients with histopathologically confirmed head-and-neck soft-tissue sarcoma that is recurrent/metastatic after surgery with no curative-intent treatment (surgery/radiotherapy) options, or locally advanced unresectable disease; with measurable lesions (≥10 mm on spiral CT scan, meeting RECIST 1.1 criteria).
- 3. Have previously received at least one cycle of doxorubicin-containing chemotherapy, with radiologically confirmed disease progression or judged by the investigator to derive no further clinical benefit from prior therapy. Prior chemotherapy must have been completed at least 4 weeks before the first study drug administration, and all treatment-related toxicities must have resolved to baseline or to Grade 1 or lower per CTCAE Version 5.0.
- 4. Malignant tumors with immunohistochemically-verified deficiency of the SWI/SNF (BAF) complex (including ARID1A, ARID1B, SMARCA2 (BRM), SMARCA4 (BRG1), SMARCB1 (INI1), etc.).
- 5. Accessible evaluable tumor tissue (paraffin-embedded specimen obtained within the past 2 years or fresh tumor tissue).
- 6. ECOG performance status of 0 or 1. 7. Expected survival ≥12 weeks. 8. Adequate major organ function within 2 weeks prior to treatment initiation, as defined below: i. Bone marrow: hemoglobin ≥100 g/L without transfusion or colony-stimulating factor support; white blood cell count ≥4.0 × 10⁹/L or absolute neutrophil count ≥2.0 × 10⁹/L; platelet count ≥100 × 10⁹/L.
Key exclusion criteria (25 listed)
- 1. Patients previously treated with anlotinib or EZH1/2 / EZH2 inhibitors. 2. Re-irradiation to the head-and-neck region (including cervical, supraclavicular and infraclavicular lymph nodes) within 6 months prior to enrollment.
- 3. Tumor encasement, invasion or infiltration of major blood vessels; tumor invasion into skin or mucosal cavities; or ulcerated/bleeding tumor lesions.
- 4. Known hypersensitivity to anlotinib, zemetostat, or any of their excipients. 5. Concurrent use of known moderate- or strong-inducers / inhibitors of CYP3A4 / CYP3A5, or P-gp inhibitors.
- 6. Uncontrolled hypertension despite anti-hypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- 7. Any condition impairing oral drug ingestion, or any condition altering drug disposition (absorption, distribution, metabolism or excretion) in vivo.
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 |
|---|---|---|
| zemetostat combined with anlotinibEnrolled patients receive zemetostat plus anlotinib until discontinuation criteria are met. The specific dosing regimen is as follows: zemetostat 350 mg orally twice daily (bid po). The recommended dose of anlotinib is 12 mg once daily for 14 consecutive days, followed by a 7-day drug-free interval (2/1 schedule), constituting a 21-day treatment cycle. Doses should be taken at approximately the same time each day. If a patient vomits or misses a dose, no supplemental dose should be administered on that day; the subsequent scheduled dose should be taken as usual. | Drug | zemetostat combined with anlotinib |
Primary outcome
Progression Free Survival
Time frame: 12 months
PFS was defined as the time from enrollment to the first documented PD per RECIST 1.1, or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum had to demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD
3 secondary outcomes
objective response rate
Time frame: 12 months
overall survival
Time frame: 12 months
Number of Participants Experiencing an Adverse Event (AE)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Yue He, M.D. principal investigator
the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zemetostat combined with anlotinib in people with Soft Tissue Sarcoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 13 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 5 Nov 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 phase mean?
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guoxin Ren, M.D. (13916948812, renguoxincn@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 12 months). 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 5 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.