Pharmacology & human Phase 1 safety & dose escalation studies using anti-GP88 in aggressive breast cancer
药理
基本信息
- 批准号:10252075
- 负责人:
- 金额:$ 82.69万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2018
- 资助国家:美国
- 起止时间:2018-09-01 至 2025-02-28
- 项目状态:未结题
- 来源:
- 关键词:AcuteAddressAnimalsAntineoplastic AgentsAromatase InhibitorsBiologicalBiological MarkersBiological Response Modifier TherapyBloodBlood TestsBlood specimenBreast Cancer ModelBreast Cancer PatientBreast Cancer Risk FactorCell LineCessation of lifeChemistryClinicalClinical ResearchClinical TrialsComprehensive Cancer CenterDataDepositionDiagnostic testsDiseaseDocumentationDoseDrug resistanceEnrollmentEstrogen AntagonistsEstrogen receptor positiveEventFormulationFutureGlycoproteinsGrowthHormonesHumanImageIndividualInjectableInstitutional Review BoardsInvestigationLife ExpectancyLinkLiquid substanceMalignant NeoplasmsMammary Gland ParenchymaMarylandMaximum Tolerated DoseMeasurableMeasuresMonoclonal AntibodiesMusNatureOutcomePGRN genePathologicPatient MonitoringPatientsPharmaceutical PreparationsPharmacologic SubstancePharmacologyPharmacology StudyPhasePlayPopulationPopulation DecreasesProcessProductionRadiation therapyRecombinantsRecurrenceResistanceRoleSafetyScheduleSerumSmall Business Innovation Research GrantSolid NeoplasmStable DiseaseTestingTherapeuticTissue BanksTissuesToxic effectToxicologyTumor TissueUniversitiesVial deviceXenograft ModelXenograft procedureadverse event monitoringaggressive breast cancerautocrinebasebreast cancer diagnosiscancer cellchemotherapycohortcompanion diagnosticscostcost effectivedesigndrug discoveryfirst-in-humanimmunogenicityimprovedin vivoinnovationintravenous injectionmalignant breast neoplasmneutralizing antibodynew therapeutic targetnonhuman primatenovel strategiesopen labeloverexpressionpre-clinicalprecision medicinepreclinical developmentpreclinical efficacypredictive markerreal time monitoringresponsesuccesstargeted treatmenttheranosticstherapeutic targettherapy developmenttreatment choicetriple-negative invasive breast carcinomatumortumor growthtumorigenesis
项目摘要
In 2017, ~200,000 new cases of breast cancer (BC) and ~40,000 related deaths are expected in the US. ~30,000
of these are patients with aggressive triple negative BC (TNBC) or anti-estrogen/aromatase inhibitor resistant
(AE/AI) BC that do not have targeted therapy and rely on radiotherapy and aggressive chemotherapy. A new
approach that benefits these patients and provides increased life expectancy needs to be developed. We have
identified GP88, a glycoprotein that is produced by cancer cells and stimulates their growth and survival leading
to formation of more aggressive tumors. GP88 is found in BC but not in normal breast tissue. There is compelling
biological and clinical evidence to suggest that GP88 can be used to develop novel targeted therapy with
companion diagnostics that could impact treatment and improve survival of TNBC and AE/AI BC patients. We
have developed a tissue test to identify patients with tumors expressing GP88 and an anti-GP88 (AG1) to block
the action of GP88 on tumor tissues to a) inhibit tumor growth and b) increase the efficacy of current BC drugs.
We have safety and efficacy data in animals and will in our Phase 1 develop a dosing strategy in mice before
moving into human studies as part of the Phase 2. Additionally, a blood test has been developed to monitor
patients while on treatment. Using AG1 as the therapy with two companion diagnostic tests, we will carry out a
phase IA/B clinical trial in humans to determine safety of AG1 manufactured under GMP in the Phase 2 and will
collect tumor tissue and blood on all patients to evaluate for GP88 expression (tissue) and concentration (blood).
2017年,美国预计将新增约20万例乳腺癌(BC)病例和约4万例相关死亡。~30,000
其中有侵袭性三阴性BC(TNBC)或抗雌激素/芳香酶抑制剂耐药的患者
(AE/AI)BC,没有靶向治疗,依靠放射治疗和积极的化疗。一种新的
需要开发一种使这些患者受益并延长预期寿命的方法。我们有
确定了GP88,一种由癌细胞产生并刺激其生长和存活的糖蛋白
形成更具侵袭性的肿瘤。在BC中发现了GP88,但在正常乳腺组织中没有发现。有令人信服的
生物学和临床证据表明,GP88可用于开发新的靶向治疗
伴随诊断,可影响治疗并提高TNBC和AE/AI BC患者的存活率。我们
我开发了一种组织测试来识别表达GP88和抗GP88(AG1)的肿瘤患者
GP88对肿瘤组织的作用是:a)抑制肿瘤生长;b)提高现有BC药物的疗效。
我们已经有了动物的安全性和有效性数据,并将在我们的第一阶段开发一种在小鼠身上的给药策略
作为第二阶段的一部分进入人体研究。此外,已经开发了一种血液测试来监测
患者在治疗过程中。使用AG1作为治疗方法,并进行两项伴随的诊断试验,我们将进行一项
人体IA/B期临床试验,以确定在GMP下生产的AG1在第二阶段的安全性,并将
收集所有患者的肿瘤组织和血液,以评估GP88的表达(组织)和浓度(血液)。
项目成果
期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Ginette Serrero其他文献
Ginette Serrero的其他文献
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{{ truncateString('Ginette Serrero', 18)}}的其他基金
Pharmacology & human Phase 1 safety & dose escalation studies using anti-GP88 in aggressive breast cancer
药理
- 批准号:
10245772 - 财政年份:2018
- 资助金额:
$ 82.69万 - 项目类别:
A Circulating Biomarker for use in Monitoring Metastatic Breast Cancer
用于监测转移性乳腺癌的循环生物标志物
- 批准号:
9768982 - 财政年份:2017
- 资助金额:
$ 82.69万 - 项目类别:
A Circulating Biomarker for use in Monitoring Metastatic Breast Cancer
用于监测转移性乳腺癌的循环生物标志物
- 批准号:
10477924 - 财政年份:2017
- 资助金额:
$ 82.69万 - 项目类别:
Granulin specific monoclonal antibodies to investigate their expression and role
颗粒蛋白特异性单克隆抗体研究其表达和作用
- 批准号:
8624365 - 财政年份:2013
- 资助金额:
$ 82.69万 - 项目类别:
Granulin specific monoclonal antibodies to investigate their expression and role
颗粒蛋白特异性单克隆抗体研究其表达和作用
- 批准号:
8729517 - 财政年份:2013
- 资助金额:
$ 82.69万 - 项目类别:
Targeted Therapy for Non Small Cell Lung Carcinoma: In vivo Feasibility Studies
非小细胞肺癌靶向治疗:体内可行性研究
- 批准号:
8312247 - 财政年份:2012
- 资助金额:
$ 82.69万 - 项目类别:
Serum GP88 biomarker as a surrogate marker for disease progression in breast canc
血清 GP88 生物标志物作为乳腺癌疾病进展的替代标志物
- 批准号:
8058236 - 财政年份:2011
- 资助金额:
$ 82.69万 - 项目类别:
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