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

Sponsor
National University Hospital, Singapore
Study ID
NCT07681297
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tislelizumab + Bevacizumab + Capecitabine — DRUG
    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

Study Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Aug 31, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
154 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib: Dose-Finding / Safety Confirmation
    Patients with advanced solid tumors will be enrolled into a standard 3+3 design. Dose escalation will proceed using two predefined dose levels (DL1 and DL-1). There will be no dose reductions permitted for either tislelizumab or bevacizumab; dose modifications, if required, will apply only to capecitabine in accordance with protocol-defined guidelines. If the DL-1 dose level is not tolerated, further dose de-escalation is not pre-specified. In such a scenario, a formal review will be undertaken in consultation with the Study's Scientific Committee to determine the appropriate next steps, including consideration of additional dose reduction strategies or discontinuation of further dose exploration for the combination.
  • Experimental: Phase II: Multi-Cohort Expansion - PD-L1 negative TNBC cohort
  • Experimental: Phase II: Multi-Cohort Expansion - Active CNS disease cohort
  • Experimental: Phase II: Multi-Cohort Expansion - HR+/HER2- MBC cohort

Primary Outcome Measure

Phase Ib: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 2 years ]

Central Contacts

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