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Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease

NCT07681297 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2026-07-10

No results posted yet for this study

Summary

This study is designed to establish the safety of the combination of PD-1 inhibitor tislelizumab, an anti-angiogenic agent bevacizumab and a chemotherapeutic agent capecitabine, in a phase Ib setting and to evaluate preliminary efficacy in selected expansion cohorts, including PD-L1-negative metastatic triple negative breast cancer (TNBC) and patients with active CNS disease. A sequential approach to cohort expansion will allow further evaluation in hormone receptor positive (HR+), HER2 negative (HER2-) disease if a signal of activity is observed in PD-L1 negative TNBC.

Conditions

  • Advanced Solid Tumor Cancer
  • Triple-Negative Breast Cancer (TNBC)
  • CNS Disease
  • Breast Cancer

Interventions

DRUG

Tislelizumab + Bevacizumab + Capecitabine

Phase Ib Dose Levels Dose Level DL1 (Starting Dose) * Tislelizumab: 200 mg IV Day 1 q3w * Bevacizumab: 7.5 mg/kg IV Day 1 q3w * Capecitabine: 1000 mg/m² PO BID Days 1-14 q3w DL-1 (De-escalation) * Tislelizumab: 200 mg IV Day 1 q3w * Bevacizumab: 7.5 mg/kg IV Day 1 q3w * Capecitabine: 800 mg/m² PO BID Days 1-14 q3w

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Soo Chin Lee · National University Hospital, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07681297 on ClinicalTrials.gov