Zemetostat With Anlotinib in Patients With Recurrent/Metastatic Head and Neck Soft Tissue Sarcoma

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

Trial Details

NCT ID
NCT07917949
Phase
PHASE2
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • zemetostat combined with anlotinib
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • 1\. Aged 18-75 years, regardless of gender. 2. Patients with histopathologically confirmed head-and-neck soft-tissue sarcoma that is recurrent/meta…
  • 3\. Have previously received at least one cycle of doxorubicin-containing chemotherapy, with radiologically confirmed disease progression or judged…
  • 4\. Malignant tumors with immunohistochemically-verified deficiency of the SWI/SNF (BAF) complex (including ARID1A, ARID1B, SMARCA2 (BRM), SMARCA4 …
  • 5\. Accessible evaluable tumor tissue (paraffin-embedded specimen obtained within the past 2 years or fresh tumor tissue).

For full eligibility, visit ClinicalTrials.gov.

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