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Clinical Trials/EUCTR2016-003608-30-ES
EUCTR2016-003608-30-ESActive, not recruitingPhase 1

A Phase II, Multi Center Study of BGB324 in combination with Pembrolizumab in Patients with Previously Treated, Locally Advanced and Unresectable or Mestastic Triple Negative Breast Cancer (TNBC) or Triple Negative Inflammatory Breast Cancer (TN-IBC)

BerGenBio AS0 sites56 target enrollmentStarted: March 31, 2017Last updated:
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Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
56
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Provision of signed informed consent.2. Age 18 years or older at the time of provision of informed consent.3. Histopathologically or cytologically documented TNBC or TN-IBC. Tumors must have been confirmed negative for ER and PR by IHC (<1% positive tumor nuclei, as per ASCO-CAP guideline recommendations3) and negative for HER2 by IHC or fluorescent or chromogenic in situ hybridization (FISH or CISH). Patients with equivocal HER2 results by IHC should have their negativity status confirmed by FISH. 4. Locally advanced and unresectable or metastatic TNBC or triple negative inflammatory breast cancer. 5. Received one or more prior therapies for TNBC or TN-IBC, which may include adjuvant, neo-adjuvant and metastatic therapy, and must have included a prior taxane and/or anthracycline-based therapy 6. Has measurable disease as defined by RECIST 1.12 on computed tomography (CT) or magnetic resonance imaging (MRI) and as determined by the site study team. Tumor lesions situated in a previously irradiated area are considered measurable if progression
  • •has been demonstrated in such lesions.
  • •7. Provision of suitable tumor tissue for the analysis of Axl kinase expression and PD-L1
  • •expression. Suitable tumor tissue must consist of a minimum of newly acquired (fresh)
  • •tumor tissue sample (as a FFPE block), together with either further newly acquired
  • •tumor tissue (i.e. further FFPE block) or an archival tumor tissue sample (as a further
  • •FFPE block or further 10 unstained slides). See Section 5.3.13 for further details.
  • •8. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1 [Appendix
  • •9. Life expectancy of at least 3 months.
  • •10. Adequate organ function confirmed at Screening and within 10 days of initiating
  • •treatment, as evidenced by:
  • •a. Platelet count =100,000 /mm3;
  • •b. Hemoglobin =9.0 g/dL (=5.6 mmol/L);
  • •c. Absolute neutrophil count (ANC) >1,500 /mm3;
  • •d. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) =2.5
  • •times the upper limit of normal (ULN), or =5 times the ULN for patients with
  • •liver metastases;
  • •e. Total bilirubin =1.5 times the ULN, or direct bilirubin total bilirubin levels >1.5xULN;
  • •f. Creatinine =1.5 times the ULN and calculated creatinine clearance >60 mL/min
  • •(by Cockcroft Gault formula; see Appendix B);
  • •g. International Normalized Ratio (INR) or Prothrombin Time (PT) =1.5 times the
  • •ULN and Activated Partial Thromboplastin Time (aPTT) =1.5 times the ULN.
  • •Note: If patient is receiving anticoagulant therapy, then PT or PTT must be
  • •within therapeutic range of intended use of anticoagulants;
  • •h. LDH =2.5 times the ULN.
  • •11. Female patients of childbearing potential must have a negative pregnancy test (either
  • •urine or serum pregnancy test) within 72 hours prior to the first dose of study treatment.
  • •If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test
  • •will be required.
  • •12. Have resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or
  • •less (except alopecia). If the patient received major surgery or radiation therapy of >30
  • •Gy, they must have recovered from the toxicity and/or complications from the
  • •intervention.
  • •13. Patients of reproductive potential must be willing to practice highly effective methods
  • •of contraception (such as those described in Section 6.13) throughout the study and for
  • •120 days after the last dose of study medication. Abstinence is acceptable if this is the
  • •usual lifestyle of the patient. Female patients are

Exclusion Criteria

  • •1. Has disease that is suitable for local therapy administered with curative intent.
  • •2. More than 3 previous lines of therapy in the metastatic setting.
  • •3. Has received prior therapy with an immunomodulatory agent.
  • •4. Has a known additional malignancy that is progressing or requires active treatment.
  • •5. Has known active central nervous system (CNS) metastases and/or carcinomatous
  • •meningitis.
  • •6. History of the following cardiac conditions:
  • •a. Congestive cardiac failure of >Grade II severity according to the
  • •b. Ischemic cardiac event including myocardial infarction within 3 months prior to
  • •first dose;
  • •c. Uncontrolled cardiac disease, including unstable angina, uncontrolled
  • •hypertension or need to change medication due to lack of disease control within 6
  • •weeks prior to the provision of consent;
  • •d. History or presence of sustained bradycardia (=55 BPM), left bundle branch
  • •block, cardiac pacemaker or ventricular arrhythmia.
  • •e. Family history of long QTc syndrome; personal history of long QTc syndrome
  • •or previous drug-induced QTc prolongation of at least Grade 3 (QTc >500 ms).
  • •7. Abnormal left ventricular ejection fraction on echocardiography or MUGA
  • •8. Current treatment with any agent known to cause Torsades de Pointes which cannot
  • •be discontinued at least five half-lives or two weeks prior to the first dose of study
  • •9. Screening 12-lead ECG with a measurable QTc interval according to Fridericia’s
  • •correction >450 ms.
  • •10. Is currently participating and receiving study therapy or has participated in a study of
  • •an investigational agent and received study therapy or used an investigational device
  • •within 4 weeks of the first dose of study treatment.
  • •11. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy
  • •within 2 weeks prior to study Day 1 or who has not recovered from AEs due to a previously administered agent.
  • •12. Received an anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first
  • •dose of study treatment or who has not recovered from AEs
  • •due to agents administered more than 4 weeks earlier.
  • •13. Major surgery within 28 days prior to start of study treatment and failure to have
  • •recovered adequately from the toxicity and/or complications from the intervention
  • •prior to the first dose of study treatment.
  • •14. Received transfusion of blood products (including platelets or red blood cells) or
  • •administration of colony stimulating factors (including G-CSF, GM-CSF or
  • •recombinant erythropoetin) within 4 weeks prior to the first dose of study treatment.
  • •15. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
  • •other form of immunosuppressive therapy within 7 days prior to the first dose of study
  • •16. Active autoimmune disease that has required systemic treatment in past 2 years
  • •Note: Replacement therapy is not considered a
  • •form of systemic treatment.
  • •17. Known history of human immunodeficiency virus (HIV 1/2 antibodies)
  • •18. Has known active infection with Hepatitis B or Hepatitis C
  • •19. Has received a live-virus vaccination within 30 days of planned treatment start. Note:
  • •Seasonal flu vaccines that do not contain live virus are permitted.
  • •20. Has a history of (non-infectious) pneumonitis that required steroids or current
  • •pneumonitis.
  • •21. Has a history of interstitial lung disease.
  • •22. Inability to swallow or tolerate oral medication.
  • •23. Existing gastrointestinal disease affecting drug absorption such as celiac disease or
  • +1 more not shown

Investigators

Sponsor
BerGenBio AS

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