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

Summary

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.

Conditions

• Malignant Solid Tumor
• Brain Metastasis

Interventions

DRUG

Utidelone

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.

DRUG

Bevacizumab

Bevacizumab

Sponsors & Collaborators

• Beijing Baiyang Zhihe Medical Technology Transfer Services Co., Ltd.

  collaborator UNKNOWN

• Innovent Biologics (Suzhou) Co. Ltd.

  collaborator INDUSTRY

• Tianjin Medical University Cancer Institute and Hospital

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2028-02-01

Completion

2030-02-01