NL-OMON53713撤回不适用
A Phase 1b/2, open-label dose escalation with expansion study of GB5121 in adult patients with relapsed/refractory primary or secondary central nervous system lymphoma or primary vitreoretinal lymphoma, with a Phase 2 open-label single dose level study of GB5121 in adult patients with relapsed/refractory primary central nervous system lymphoma - GB5121-2101 STAR CNS
GB005, Inc., a wholly-owned subsidiary of Gossamer Bio, Inc.0 个研究点目标入组 22 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Phase 1b Dose Escalation and Expansion:
- •1. Patients who are at least 18 years of age at the time of signing the
- •informed consent form (ICF) prior to initiation of any study specific
- •activities/procedures.
- •2. Patients must have histologically/cytologically confirmed PCNSL, primary
- •vitreoretinal lymphoma (PVRL), or CNS-only involvement of a systemic B-cell
- •3. All patients must have relapsed/refractory disease and must have received
- •all possible standard-of-care CNS-directed treatment regimens or patients for
- •which further standard-of-care treatment options are contraindicated or
- •4. Patients must be able to tolerate gadolinium-enhanced MRI scans, or
- •contrast-enhanced CT .
- •5. Patients with parenchymal lesions must have baseline imaging
- •(gadolinium-enhanced MRI or if contraindicated, contrast-enhanced CT, of the
- •brain) within 28 days prior to first study drug dose. For patients with
- •leptomeningeal disease only, CSF cytology must document lymphoma cells and/or
- •imaging findings consistent with leptomeningeal disease after informed consent
- •and prior to first study dose (at the discretion of the Investigator).
- •6. Patients with parenchymal lesions must have measurable disease (disease that
- •has at least one lesion >= 10 mm in the longest diameter) on imaging
- •(gadolinium-enhanced MRI or if contraindicated, contrast-enhanced CT, of the
- •brain) prior to first study dose.
- •7. Patients must be able to tolerate and consent for a lumbar puncture and/or
- •have pre-existing placement of an Ommaya reservoir, unless clinically
- •contraindicated.
- •8. Patients must have recovered to <= Grade 1 toxicity from prior therapy.
- •9. Patients, when available, should be able to submit at minimum 3 and up to 20
- •unstained formalin-fixed, paraffin-embedded (FFPE) slides from the initial
- •tissue diagnosis, preferably prior to study enrollment.
- •10. Patients must have a performance status of 0, 1, or 2 on the Eastern
- •Cooperative Oncology Group (ECOG) Performance Scale.
- •11. Demonstrate adequate bone marrow and organ function as defined in the
- •protocol. All screening laboratories for organ functions should be performed
- •within 14 days of initiating the study drug.
- •12. Female patients must be:
- •a. Of non-childbearing potential: Evidence of post-menopausal status. Refer to
- •Appendix 4 (Section 10.4) for definitions; or
- •b. If of childbearing potential, patient must use a highly effective method of
- •contraception for the duration of treatment and for at least 30
- •days following the last dose of GB5121. Refer to Appendix 4 (Section 10.4) for
- •contraception guidance.
- •c. Female patients of childbearing potential must have a negative serum or
- •urine pregnancy test within 72 hours prior to receiving the first
- •dose of study drug.
- •13. Male patients who are not abstinent who are partners of women of
- •childbearing potential must use 2 highly effective method of contraception
- •throughout the entire study period. Refer to Appendix 4 (Section 10.4) for
- •contraception guidance. Those with partners using hormonal contraceptives must
- •also be using an additional approved method of contraception (as described
- •previously).
- •14. Male and female patients must refrain from donating sperm or eggs from
- 另有 2 项未显示
排除标准
- •Phase 1b Dose Escalation and Expansion:
- •1. Patients are concurrently using other approved or investigational
- •antineoplastic agents.
- •2. Patients have an active concurrent malignancy requiring active therapy.
- •3. Patients are allergic to components of the study drug (Section 5.1).
- •4. Patients have a known bleeding diathesis (eg, von Willebrand's disease) or
- •hemophilia.
- •5. Patients who require therapeutic anticoagulation, including dual
- •antiplatelet agents. Patients who have received therapeutic anticoagulation,
- •including dual antiplatelet agents, within 5 half-lives of the anticoagulant,
- •or 14 days, whichever is longer, prior to starting the study drug. Patients who
- •require the use of antiplatelet agents should be discussed with the Sponsor's
- •Medical Monitor.
- •6. Patients have significant abnormalities on screening electrocardiogram (ECG)
- •and active and significant cardiovascular disease such as uncontrolled or
- •symptomatic arrhythmias, congestive heart failure, uncontrolled hypertension,
- •valvular disease, pericarditis, or myocardial infarction within 6 months of
- •7. Patients with any of the following will be excluded:
- •a. A marked baseline prolongation of QT/QTc interval (eg, repeated
- •demonstration of a QTc interval > 480 ms [CTCAE grade 2]) using Frederica's QT
- •correction formula.
- •b. A history of additional risk factors for Torsades de Pointes (eg, heart
- •failure, hypokalemia, family history of long QT syndrome).
- •c. The use of concomitant medications that prolong the QT/QTc interval (Section
- •8. Patients are known to have a history of active or chronic infection with
- •hepatitis C virus (HCV), hepatitis B virus (HBV), as determined by serologic
- •9. Known history of infection with HIV.
- •10. Patients are known to have an uncontrolled active infection.
- •11. Patients have a history of stroke or intracranial hemorrhage within 6
- •months prior to enrollment.
- •12. Patients have a life-threatening illness, medical condition, or organ
- •system dysfunction that, in the opinion of the Investigator, could compromise
- •the patient's safety or put the study outcomes at undue risk.
- •13. Patients have an inability to swallow capsules or tablets, or disease
- •significantly affecting gastrointestinal function and/or inhibiting small
- •intestine absorption (including malabsorption syndrome, resection of the small
- •bowel, or poorly controlled inflammatory bowel disease).
- •14. Women who are pregnant or nursing (lactating).
- •15. Patients have received chemotherapy, monoclonal antibodies, or targeted
- •anticancer therapy within <= 2 weeks or 5 half-lives, whichever is longer, prior
- •to starting the study drug, or the patient has not recovered from the side
- •effects of such therapy.
- •16. Patients have received external beam radiation therapy (WBRT, SRS) to the
- •CNS within 21 days of the first dose of the study drug.
- •17. Patients do not meet prior and concomitant medication criteria (Section
- •18. Patients have previously received a BTK inhibitor. Patients who have
- •previously received a BTK inhibitor, but discontinued therapy for reasons other
- •than disease progression are eligible.
- •19. Patients require > 8 mg/day of dexamethasone or the equivalent.
- •20. Patients underwent major systemic surgery within <= 2 weeks prior to
- 另有 1 项未显示
研究者
相似试验
进行中（未招募）
1 期
A study of GB5121 in adults with cancer of the central nervous system that has reappeared or did not respond to prior therapyRelapsed/refractory primary or secondary central nervous system lymphoma or primary vitreoretinal lymphomaMedDRA version: 21.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10036685Term: Primary central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-006234-39-SEGB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
进行中（未招募）
1 期
A study of GB5121 in adults with cancer of the central nervous system that has reappeared or did not respond to prior therapyRelapsed/refractory primary or secondary central nervous system lymphoma or primary vitreoretinal lymphomaMedDRA version: 21.0Level: PTClassification code 10007953Term: Central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10036685Term: Primary central nervous system lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-006234-39-NLGB005, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.143
进行中（未招募）
1 期
study to evaluate the safety of the study drug, GSK2857916, at different doses and how well it works to treat people with multiple myeloma when taken together with Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B).Relapsed / Refractory Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2017-004689-93-GBGlaxoSmithKline Research & Development Ltd152
进行中（未招募）
1 期
study to evaluate the safety of the study drug, GSK2857916, at different doses and how well it works to treat people with multiple myeloma when taken together with Lenalidomide Plus Dexamethasone (Treatment Arm A), or Bortezomib Plus Dexamethasone (Treatment Arm B).EUCTR2017-004689-93-ESGlaxoSmithKline Research & Development Ltd90
招募中
不适用
A Phase I/IIa Open-label Dose Escalation and Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD7789, an anti-PD-1 and anti-TIM-3 Bispecific Antibody, in Participants with Advanced or Metastatic Solid TumorsMaagdarmstelselneoplasmata benigneMetatstatic Solid TumorsSolid tumors10038666NL-OMON56048Astra Zeneca14