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临床试验/EUCTR2013-001699-39-NL
EUCTR2013-001699-39-NL进行中（未招募）1 期

A phase I, first time in human, open-label, dose escalation study to investigate the safety, pharmacokinetics, and pharmacodynamics of anti-HER3 monoclonal antibody GSK2849330 in subjects with advanced HER3-positive solid tumors

GlaxoSmithKline Research Development Ltd0 个研究点目标入组 154 人开始时间: 2015年2月12日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
154
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •For Inclusion criteria please view the following sections within the protocol.
  • •For Pre-screening Inclusion Criteria for Part 1 & 2 see protocol section 5.2.1 -5.2.2. P 60-61.
  • •For Screening Inclusion Criteria for Parts 1 and 2 see below
  • •1. Males and females =18 years of age (at the time consent is obtained).
  • •2. Written informed consent provided.
  • •3. For subjects enrolled in Part 1:subjects must have tumors with documented HER3 expression (2+ or 3+) on the cell surface of the invasive component of the tumor (either on archival tissue or fresh tumor biopsy) using an analytically validated IHC assay by central laboratory (see protocol section 7.6.1.1 for details). Subjects enrolled in Part 2 must meet inclusion criterion 9 listed below.
  • •4. ECOG performance status of 0 or 1 (see protocol Appendix 3).
  • •5. Adequate baseline organ function defined by: Please see table for further information.
  • •6. If the subject is female, she must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception, as defined in protocol Section 11.1.1, from the time of the first dose of study treatment until 45 days or 5 half-lives (whichever is longer) after the last dose of study treatment.
  • •7. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception as described in Section 11.1.2 from the time of the first dose of study treatment until 45 days or 5 half-lives (whichever is longer) after the last dose of study treatment to allow for clearance of GSK2849330 in seminal fluid.
  • •8. Subjects enrolled as part of the PK/PD cohort (Part 1) must agree to undergo preand on-treatment tumor biopsies.
  • •For Inclusion Criteria for Part 2 ONLY section 5.2.4. of the protocol
  • •As listed above for Part 1, with the exception of criterion 3 which should be replaced with the following criterion 9 and the addition of criteria 10 and 11.
  • •9. For Group 1: subjects with previously treated, unresectable stage III
  • •or IV melanoma with documented HER3 expression (3+) on the cell
  • •surface of the invasive component of the tumor (either on archival
  • •tumor or fresh tumor biopsy) using an analytically validated IHC
  • •assay by central laboratory.
  • •- Subjects must have no more than 3 prior lines of systemic regimens
  • •and have disease progression on or after last prior treatment (based
  • •on RECIST v1.1).
  • •- Subjects with BRAF V600 mutations who already received or were
  • •intolerant of prior BRAF inhibitor therapy may be included. BRAF
  • •V600 inhibitor-naïve subjects will be eligible if a BRAF inhibitor is not
  • •available to them commercially or via a clinical trial.
  • •- Subjects may be included if they had prior immune therapy, were
  • •intolerant of prior immune therapy, or if such therapy is not available to
  • •them commercially or via a clinical trial.
  • •For Group 2: Subjects with previously treated, unresectable stage III or IV gastric or gastroesophageal junction (GEJ) adenocarcinoma with documented HER3 expression (3+) on the cell surface of the invasive component of the tumor (either on archival tumor or fresh tumor biopsy) using an analytically validated IHC assay by central laboratory.
  • •- Subjects must have no more than 3 prior lines of systemic regimens
  • •and have disease progression

排除标准

  • •1. Subjects with leptomeningeal or brain metastases or spinal cord compression.
  • •- Subjects with untreated brain or meningeal metastases are not eligible
  • •(computed tomography [CT] scans are not required to rule this out
  • •unless there is a clinical suspicion of central nervous system [CNS]
  • •- Subjects with treated and radiologic or clinical evidence of stable brain
  • •metastases (confirmed by 2 scans at least 4 weeks apart), with no
  • •evidence of cavitation or hemorrhage in the brain lesion are eligible
  • •providing that they are asymptomatic and do not require
  • •corticosteroids. Subjects are not permitted to receive enzyme inducing
  • •anti-epileptic drugs.
  • •2. Prior HER3- directed treatment (HER2- or EGFR-directed treatment is
  • •acceptable).
  • •3. Use of an investigational anti-cancer drug within 28 days (or 5 half
  • •-lives, whichever is longer) preceding the first dose of GSK2849330
  • •OR chemotherapy within the last 3 weeks (6 weeks for prior
  • •nitrosourea or mitomycin C) OR any major surgery, radiotherapy, immunotherapy or any other anti-cancer therapy within the last
  • •4 weeks, except as noted above.
  • •4. Unresolved toxicity greater than NCI-CTCAE, version 4.0 [NCI, 2009]
  • •Grade 1from previous anti-cancer therapy except alopecia and stable
  • •anemia (i.e.,untransfused Hb =9.0 g/dL without the need for supportive transfusion within 2 weeks of screening) at the time of treatment
  • •allocation.
  • •5. Known or suspected hypersensitivity reaction to prior biologic
  • •therapy (e.g., therapeutic monoclonal antibody) that in the opinion
  • •of the investigator is a contraindication to their participation in
  • •6. Current use of a prohibited medication or requires any of these medications
  • •during treatment (protocol Section 10.2).
  • •7. History or evidence of significant cardiovascular risk including any of
  • •the following:
  • •- LVEF <50%
  • •-A QT interval corrected for HR (QTc) = 480 msec (=500 msec for subjects
  • •with bundle branch block)
  • •- History or evidence of current clinically significant uncontrolled
  • •arrhythmias.
  • •Exception: Subjects with controlled atrial fibrillation for >30 days
  • •prior to enrollment are eligible.
  • •- History of acute coronary syndromes (including myocardial infarction
  • •and unstable angina), coronary angioplasty, or stenting within 6 months
  • •prior to enrollment.
  • •- History or evidence of current = Class II congestive heart failure as
  • •defined by New York Heart Association (NYHA).
  • •8. Known human immunodeficiency virus (HIV), hepatitis B virus (HBV),
  • •or hepatitis C virus (HCV) infection (with the exception of chronic or
  • •cleared HBV and HCV infection which will be allowed).
  • •9. Evidence of another active malignancy (excludes non-melanoma skin cancer). Consult GSK Medical Monitor if unsure whether second
  • •malignancies meet requirements specified above.
  • •10. Psychological, familial, sociological, or geographical conditions
  • •that do not permit compliance with the protocol.
  • •11. Concurrent medical condition that in the investigator’s opinion
  • •would jeopardize compliance with the protocol.
  • •12. Lactating female.
  • 另有 2 项未显示

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