A Phase II Clinical Study of Utidelone and Bevacizumab With or Without Etoposide in Patients With Brain Metastases From Malignant Solid Tumors

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07449481
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Brain Metastasis
  • Malignant Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Utidelone — DRUG
    Treatment Plan for Patients with Lung Cancer Brain Metastases: Utidelone Injection: 30 mg/m²/day by intravenous infusion, administered on Days 1 to 5, in a 21-day treatment cycle. Bevacizumab: 5-7.5 mg/kg, administered on Day 1, in a 21-day treatment cycle. Treatment Duration: The combination therapy should be administered for at least 4 to 6 cycles. If the patient achieves disease response or stability, the combination regimen may be continued. Treatment persists until disease progression (PD), unacceptable toxicity, or patient withdrawal occurs.
  • Bevacizumab — DRUG
    Bevacizumab

Study Details

Brain metastasis represents one of the worst prognostic outcomes in advanced malignant tumors. Approximately 10% to 40% of patients with solid tumors develop brain metastases, a incidence rate significantly higher than that of primary malignant brain tumors. Over 80% of patients present with multiple brain metastases at diagnosis, often precluding surgical intervention. Brain metastases typically occur in the late stages of cancer. Patients have often received multiple prior therapies and developed resistance to first- and second-line drugs, leaving limited pharmacological options. The rapid growth of intracranial tumors poses an immediate threat to life. Consequently, radiotherapy and surgery currently form the cornerstone of clinical management for these patients. Thus, developing effective systemic therapies is an urgent and unmet medical need . Utidelone, a new-generation epothilone anticancer agent, has demonstrated good efficacy and safety. Previous studies indicate that utidelone achieves higher concentrations in most tissues, including the brain, compared to plasma, suggesting its ability to readily cross the blood-brain barrier . Furthermore, a Phase III clinical trial in metastatic breast cancer showed that utidelone in combination with capecitabine significantly improved the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) compared to capecitabine alone in patients previously treated with anthracyclines and taxanes . A separate Phase II study demonstrated that bevacizumab combined with carboplatin achieved a central nervous system objective response rate (CNS ORR) of 63%, with a median PFS of 5.62 months and a median OS of 14.1 months in breast cancer patients with brain metastases . Regarding safety, utidelone has a relatively low incidence of adverse reactions aside from peripheral neurotoxicity . Based on this evidence, this proposed study aims to evaluate the efficacy and safety of utidelone and bevacizumab, combined with etoposide for breast cancer cohorts or without etoposide for lung cancer cohorts, in patients with malignant tumor brain metastases.

Key Dates

First listed
Mar 4, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2030

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Non-Small Cell Lung Cancer Cohort
    Patients with histologically confirmed non-small cell lung cancer (NSCLC) and brain metastases treated with Utidelone in combination with Bevacizumab. Utidelone Injection: 30 mg/m²/day by intravenous infusion, administered on Days 1 to 5, in a 21-day treatment cycle. Bevacizumab: 5-7.5 mg/kg, administered on Day 1, in a 21-day treatment cycle. Treatment Duration: The combination therapy should be administered for at least 4 to 6 cycles. If the patient achieves disease response or stability, the combination regimen may be continued. Treatment persists until disease progression (PD), unacceptable toxicity, or patient withdrawal occurs.
  • Experimental: Small Cell Lung Cancer brain metastasis Cohort
    Patients with histologically confirmed small cell lung cancer and brain metastases treated with Utidelone in combination with Bevacizumab。 Utidelone Injection: 30 mg/m²/day by intravenous infusion, administered on Days 1 to 5, in a 21-day treatment cycle. Bevacizumab: 5-7.5 mg/kg, administered on Day 1, in a 21-day treatment cycle. Treatment Duration: The combination therapy should be administered for at least 4 to 6 cycles. If the patient achieves disease response or stability, the combination regimen may be continued. Treatment persists until disease progression (PD), unacceptable toxicity, or patient withdrawal occurs.

Primary Outcome Measure

CNS-ORR [ Time Frame: Primary outcomes assessed from baseline until the end of study, up to 48 months. ]

Central Contacts

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