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Advanced Solid Tumor CancerPhase 1/2TIBECNCT07681297

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

A Phase 1/2 study testing Tislelizumab + Bevacizumab + Capecitabine in people with Advanced Solid Tumor Cancer and Triple-Negative Breast Cancer (TNBC), run by National University Hospital, Singapore at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Tislelizumab + Bevacizumab + Capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteSingapore
Study dates
Aug 2026to Aug 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible for enrolment if they meet all applicable general inclusion criteria and, where relevant, the cohort-specific inclusion criteria.
  • General Inclusion Criteria
  • Age 21 years or older at the time of informed consent.
  • Histologically or cytologically confirmed advanced or metastatic solid tumor.
  • Patients must have received at least one prior line of standard systemic therapy for locally advanced/unresectable or metastatic disease, OR be ineligible for, intolerant of, or have declined standard-of-care therapy, with the specific reason documented in the source records.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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  • Estimated life expectancy of at least 12 weeks.
  • At least one evaluable (measurable or non-measurable) lesion as defined by RECIST version 1.1, unless otherwise specified for a disease-specific cohort.
  • Recovery to Grade 1 or baseline from acute toxicities of prior anti-cancer therapy, except for alopecia, vitiligo, or other toxicities deemed not clinically significant by the investigator.
  • Adequate organ and marrow function within 14 days prior to first dose of study treatment, defined as follows:
  • Absolute neutrophil count ≥1.5 × 10^9/L
  • Platelet count ≥100 × 10^9/L
  • Haemoglobin ≥9.0 g/dL
  • Total bilirubin <1.5 × upper limit of normal, except in patients with known Gilbert's syndrome, in whom total bilirubin up to 3.0 × upper limit of normal is permitted provided direct bilirubin is within normal limits
  • AST and ALT <2.5 × upper limit of normal, or <5 × upper limit of normal in the presence of liver metastases
  • Calculated creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula)
  • Urine protein dipstick <2+, or if urine dipstick is 2+ or greater, 24-hour urine protein <1 g per 24 hours
  • Adequately controlled blood pressure (systolic <150mmHg, diastolic <100mmHg) with or without anti-hypertensive medication.
  • Able to swallow and retain oral medication.
  • Able to understand and willing to sign written informed consent.
  • Willing and able to comply with study visits, treatment plan, laboratory tests, imaging, and other protocol-required procedures.
  • Prior exposure to immune checkpoint inhibitors, anti-angiogenic therapy, or fluoropyrimidines is permitted, unless prohibited by cohort-specific criteria.
  • TNBC Cohort Inclusion Criteria
  • Histologically confirmed triple-negative breast cancer, defined as estrogen receptor <1%, progesterone receptor <1%, and HER2-negative according to current ASCO/CAP guidelines.
  • Metastatic or unresectable locally advanced disease not amenable to curative treatment.
  • PD-L1-negative disease, defined as combined positive score (CPS) <10 using an approved assay.
  • Candidate for first-line systemic therapy for metastatic disease.
  • Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.
  • Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.
  • Prior neoadjuvant or adjuvant chemotherapy is permitted.
  • Prior immune checkpoint inhibitor therapy in the neoadjuvant or adjuvant setting is permitted, provided it was completed at least 12 months prior to start of study treatment.
  • Prior capecitabine is permitted only in the adjuvant setting, provided it was completed at least 12 months prior to start of study treatment.
  • Patients with prior CNS disease are eligible only if CNS disease is clinically controlled, defined as asymptomatic or minimally symptomatic, does not require corticosteroids and does not require ongoing CNS-directed therapy.
  • CNS Cohort Inclusion Criteria
  • Histologically or cytologically confirmed advanced solid tumor.
  • Progressive brain metastases.
  • At least one measurable CNS lesion.
  • Leptomeningeal disease is allowed.
  • Patients receiving corticosteroids for management of CNS disease or CNS-related symptoms are eligible provided the corticosteroid dose is stable or decreasing for at least 7 days prior to first dose of study treatment.
  • Patients with driver mutations (e.g., EGFR-mutant or ALK-rearranged NSCLC, HER2+ metastatic breast cancer) must have received at least one prior line of matched systemic therapy, unless such therapy is contraindicated, not tolerated, unavailable, or the patient is otherwise unsuitable in the investigator's judgment.
  • HR-Positive/HER2-Negative Cohort Inclusion Criteria
  • Histologically confirmed hormone receptor-positive (defined as ER>1% or PR>1%), HER2-negative metastatic or unresectable locally advanced breast cancer not amenable to curative treatment.
  • Patients must have measurable or non-measurable but evaluable disease per RECIST v1.1.
  • Patients without measurable disease may be enrolled provided they have unequivocal non-measurable disease that can be adequately assessed or disease status on serial radiologic evaluations, in the opinion of the investigator.
  • Prior failure of at least one line of endocrine therapy in the advanced or metastatic setting, unless deemed endocrine-resistant in the opinion of the investigator.
  • Up to one prior line of palliative chemotherapy is permitted.
  • If prior capecitabine was given, it must not have been administered in the metastatic setting and must have been completed >12 months prior to study entry.
  • Any CNS disease must be clinically controlled, defined as asymptomatic or minimally symptomatic, must not require corticosteroids, and must not require ongoing CNS-directed therapy.

Who cannot join

  • Patients will be excluded if they meet any applicable general exclusion criterion or any relevant cohort-specific exclusion criterion.
  • General Exclusion Criteria
  • Treatment with an investigational agent within 14 days prior to first dose of study treatment.
  • Known hypersensitivity or contraindication to tislelizumab, bevacizumab, capecitabine, fluoropyrimidines, or any excipients of the study drugs.
  • Known clinically significant dihydropyrimidine dehydrogenase deficiency.
  • Uncontrolled or clinically unstable CNS disease, including poor performance status attributable to CNS disease, ongoing requirement for escalating corticosteroids, uncontrolled seizures, or rapid neurologic deterioration.
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  • Clinically significant cardiovascular disease, including uncontrolled hypertension, unstable angina, clinically significant arrhythmia, myocardial infarction, or stroke that is of clinical concern in the opinion of the investigator.
  • Significant bleeding risk or recent clinically significant hemorrhage.
  • History of gastrointestinal perforation, fistula, or intra-abdominal abscess within 6 months prior to first dose, or other conditions conferring high risk in the opinion of the investigator.
  • Non-healing wound, active ulcer, or untreated fracture.
  • Active infection requiring systemic therapy.
  • Active autoimmune disease requiring systemic immunosuppressive treatment within the past 2 years, with exceptions such as replacement therapy or other conditions judged unlikely to recur.
  • Current use of systemic immunosuppressive medication, excluding physiologic corticosteroid replacement or other permitted low-dose steroids.
  • Active pneumonitis or interstitial lung disease requiring treatment, or other clinically significant pulmonary condition that, in the opinion of the investigator, would increase the risk of study treatment.
  • Other active malignancy requiring treatment or likely to interfere with assessment of study endpoints, in the opinion of the investigator.
  • Pregnancy or breastfeeding.
  • Any serious medical, psychiatric, or social condition that, in the opinion of the investigator, would compromise patient safety, interfere with study participation, or confound interpretation of study results.
  • TNBC Cohort Exclusion Criteria
  • Prior systemic therapy for metastatic TNBC.
  • Prior capecitabine in the metastatic setting.
  • Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.
  • CNS Cohort Exclusion Criteria
  • Severely symptomatic or clinically unstable CNS disease, including rapid neurologic deterioration, uncontrolled seizures, or requirement for rapidly escalating corticosteroids.
  • CNS disease requiring immediate neurosurgical intervention or urgent radiation therapy, in the opinion of the investigator.
  • Stereotactic radiosurgery (SRS) including gamma knife, within 7 days before the first dose of study treatment.
  • Whole brain radiotherapy (WBRT) within 21 days before the first dose of study treatment.
  • Use of checkpoint inhibitor, bevacizumab, and/or capecitabine within 6 months before the first dose of study treatment.
  • HR-Positive/HER2-Negative Cohort Exclusion Criteria
  • More than one prior line of palliative chemotherapy.
  • Progressive CNS disease. Patients with progressive CNS disease should be enrolled into the CNS cohort instead.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Soo Chin Lee contact

+6567724621

soo_chin_lee@nuhs.edu.sg

Singapore1 site

  • National University Cancer Institute, Singapore, National University Health System

    Singapore

    Soo Chin Lee, +6567724621, soo_chin_lee@nuhs.edu.sg

Other trials in Singapore

About this study

Official title: Phase Ib/II Study of Tislelizumab in Combination With Bevacizumab and Capecitabine in Advanced Solid Tumors With Evaluation in Immunotherapy-Resistant and Central Nervous System Disease (TIBEC)

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.

Being tested
Tislelizumab + Bevacizumab + Capecitabine
Keywords
Tislelizumab, Bevacizumab, Capecitabine, Breast Cancer, Advanced Solid Tumour Cancer, CNS disease, Triple-Negative Breast Cancer (TNBC)
Medical subject headings
Triple Negative Breast Neoplasms, Central Nervous System Diseases, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tislelizumab + Bevacizumab + CapecitabineDrug

    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 groups in NCT07681297
Study groupRoleWhat they receive
Phase Ib: Dose-Finding / Safety ConfirmationExperimentalPatients 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.
Receives: Drug: Tislelizumab + Bevacizumab + Capecitabine
Phase II: Multi-Cohort Expansion - PD-L1 negative TNBC cohortExperimentalNot described
Receives: Drug: Tislelizumab + Bevacizumab + Capecitabine
Phase II: Multi-Cohort Expansion - Active CNS disease cohortExperimentalNot described
Receives: Drug: Tislelizumab + Bevacizumab + Capecitabine
Phase II: Multi-Cohort Expansion - HR+/HER2- MBC cohortExperimentalNot described
Receives: Drug: Tislelizumab + Bevacizumab + Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase Ib: Number and percentage of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: 2 years

  2. Phase Ib: Phase II recommended dose of capecitabine in combination with tislelizumab and bevacizumab

    Measured: 2 years

  3. Phase II TNBC Cohort: 12-month progression-free survival rate with tislelizumab, bevacizumab and capecitabine

    Measured: 12 months

  4. Phase II CNS Cohort: Intracranial objective response rate with tislelizumab, bevacizumab and capecitabine

    Measured: 2 years

  5. Phase II HR-positive/HER2-negative Cohort (if activated): 12-month progression-free survival rate with tislelizumab, bevacizumab, and capecitabine.

    Measured: 12 months

Secondary outcomes (11)

  1. Phase Ib: Incidence and severity of adverse events (AEs), including serious adverse events (SAEs) and immune-related adverse events (irAEs)

    Measured: 2 years

  2. Phase II (TNBC, HR+/HER2- MBC): Objective response rate (ORR)

    Measured: 2 years

  3. Phase II (TNBC, HR+/HER2- MBC): Disease control rate (DCR)

    Measured: 2 years

  4. Phase II (TNBC, HR+/HER2- MBC): Duration of response (DoR)

    Measured: 2 years

  5. Phase II (TNBC, HR+/HER2- MBC): Median progression-free survival (PFS)

    Measured: 2 years

  6. Phase II (TNBC, HR+/HER2- MBC): Overall survival (OS)

    Measured: 2 years

  7. Phase II CNS Cohort: Intracranial progression-free survival (iPFS)

    Measured: 2 years

  8. Phase II CNS Cohort: Objective response rate (ORR) in extracranial sites

    Measured: 2 years

  9. Phase II CNS Cohort: Disease control rate (DCR) in extracranial sites

    Measured: 2 years

  10. Phase II CNS Cohort: Median progression-free survival (PFS) in extracranial sites

    Measured: 2 years

  11. Phase II CNS Cohort: Overall survival (OS)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2026
  2. Study startAug 2026 (estimated)
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07681297
Sponsor's protocol ID
BR01/01/26
Other IDs
2026-0764
Acronym
TIBEC
Status last verified
Apr 2026
First submitted
2 Jun 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, Drake CG, Camacho LH, Kauh J, Odunsi K, Pitot HC, Hamid O, Bhatia S, Martins R, Eaton K, Chen S, Salay TM, Alaparthy S, Grosso JF, Korman AJ, Parker SM, Agrawal S, Goldberg SM, Pardoll DM, Gupta A, Wigginton JM. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med. 2012 Jun 28;366(26):2455-65. doi: 10.1056/NEJMoa1200694. Epub 2012 Jun 2.

    PubMed 22658128

  • Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, Powderly JD, Carvajal RD, Sosman JA, Atkins MB, Leming PD, Spigel DR, Antonia SJ, Horn L, Drake CG, Pardoll DM, Chen L, Sharfman WH, Anders RA, Taube JM, McMiller TL, Xu H, Korman AJ, Jure-Kunkel M, Agrawal S, McDonald D, Kollia GD, Gupta A, Wigginton JM, Sznol M. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med. 2012 Jun 28;366(26):2443-54. doi: 10.1056/NEJMoa1200690. Epub 2012 Jun 2.

    PubMed 22658127

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tislelizumab + Bevacizumab + Capecitabine in people with Advanced Solid Tumor Cancer and Triple-Negative Breast Cancer (TNBC), run by National University Hospital, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 48 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Soo Chin Lee (+6567724621, soo_chin_lee@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07681297, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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