NL-OMON53127已完成不适用
A phase I, open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3326595 in subjects with solid tumors and non-Hodgkin*s lymphoma. - GSK3326595 (9018/0006)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
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
- •A subject will be eligible for inclusion in this study only if all of the
- •following criteria apply:
- •1. Males and females *18 years of age (at the time consent is obtained)
- •NOTE: For NHL cohort ONLY, subjects must be *75 years of age at the time
- •consent is obtained
- •2. Capable of giving signed informed consent
- •3. Able to swallow and retain orally-administered medication
- •4. Eastern cooperative oncology group (ECOG) performance status (defined in
- •Appendix 3) of 0 to 2
- •5. Diagnosis of one of the following:
- •a. Part 1: Histologically- or cytological-confirmed diagnosis of non-resectable
- •or metastatic solid malignancy that has progressed on prior therapy
- •(radiographic documentation of progression is adequate for study participation)
- •b. Part 2: Histologically- or cytologically-confirmed diagnosis of metastatic
- •or non-resectable disease that has progressed on or after prior therapy (ACC
- •tablet cohort does not require prior therapy for enrollment; for all tumors,
- •radiographic documentation of progression is adequate for study participation):
- •* TNBC [estrogen receptor negative (ER-), progesterone receptor negative (PR-)
- •and human epidermal growth factor receptor 2 negative (Her2-), as defined by
- •local laboratory standards];
- •* ER+BC [estrogen receptor positive (ER+) or progesterone receptor positive
- •(PR+), human epidermal growth factor receptor 2 negative (Her2-), as defined by
- •local laboratory standards];
- •NOTE: Subjects in this cohort must have previously received therapy with a
- •cyclin-dependent kinase (CDK) 4/6 inhibitor or be considered ineligible to
- •receive therapy with these agents
- •* metastatic or non-resectable transitional cell carcinoma of the bladder,
- •ureter, or renal pelvis;
- •* recurrent GBM;
- •NOTE: Subjects with prior low-grade glioma with subsequent imaging
- •demonstrating progression to GBM may be enrolled without confirmatory biopsy on
- •a case-by-case basis after discussion with the medical monitor
- •* ACC requiring systemic therapy. In order to be eligible for enrolment, ACC
- •subjects must:
- •o have shown progression by local evaluation of scans, as per RECIST 1.1,
- •within the 13 months prior to enrolment, AND
- •o have measurable disease, as confirmed by independent central review of
- •baseline scans prior to first dose.
- •* HPV-positive solid tumor of any primary histology
- •NOTE: HPV-positive status may be determined locally via any generally accepted
- •test [e.g., HPV DNA OR p16 immunohistochemistry]. A minimum of 10 subjects
- •must be enrolled with cervical cancer;
- •* non-Hodgkin*s lymphoma that is NOT one of the following subtypes, as
- •determined by local laboratory testing:
- •o Burkitt*s lymphoma or other high-grade lymphoma
- •o Double- or triple-hit large B-cell lymphoma
- •NOTE: Any questions regarding eligibility of subtypes should be directed to the
- •medical monitor
- •* OR NSCLC, of any histologic sub-type; with local mutational analysis
- •demonstrating wild-type status of TP53 (i.e., p53 wild-type NSCLC)
- 另有 7 项未显示
排除标准
- •A subject will not be eligible for inclusion in this study if any of the
- •following criteria apply:
- •1. Malignancy attributed to prior solid organ transplant
- •2. Leptomeningeal disease, spinal cord compression, or brain metastases that
- •require immediate CNS-specific treatment in the opinion of the Investigator
- •(e.g., for symptomatic disease).
- •NOTE: Subjects who require local therapy for CNS metastases may be considered
- •for eligibility once local therapy is completed and acute treatment-related
- •toxicities have resolved
- •NOTE: Subjects with untreated lesions should be followed with intracranial
- •imaging (e.g., MRI) at each disease assessment, as detailed in Section 8.1.
- •NOTE: This criterion does not apply to subjects with GBM. In Part 1, subjects
- •with GBM may enroll provided that they are on a stable to decreasing dose of
- •corticosteroids for at least 14 days prior to the first dose of GSK3326595. In
- •Part 2, subjects with GBM may enroll irrespective of steroid dose.
- •3. Recent prior therapy, defined as follows:
- •* Any non-monoclonal anti-cancer therapy within 14 days or 5 half-lives,
- •whichever is longer, prior to the first dose of GSK3326595. Any nitrosoureas or
- •mitomycin C within 42 days prior to the first dose of GSK3326595. Prior therapy
- •with biologic agents (including monoclonal antibodies) is permitted so long as
- •28 days have elapsed since therapy and all therapy-related AEs have resolved to
- •* Grade 1, with the exception of those listed in Section 4.2.4.2. Note that
- •subjects with immunotherapy-related endocrinopathies, currently managed with
- •replacement therapy, will be allowed on study.
- •* Any radiotherapy within 14 days or major surgery within 28 days prior to the
- •first dose of GSK3326595. For subjects in the GBM cohort, subjects must have
- •completed radiation therapy at least 28 days prior to the first dose of
- •GSK3326595.
- •* Anti-androgen therapies for prostate cancer, such as bicalutamide, must be
- •stopped 4 weeks prior to enrollment. Second-line hormone therapies such as
- •enzalutamide or abiraterone should be stopped 2 weeks prior to enrollment.
- •Subjects with prostate cancer should remain on luteinizing hormone releasing
- •hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also
- •remain on low-dose prednisone or prednisolone (up to 10 mg/day) and still be
- •eligible for this study.
- •4. Part 3 only: History of any of the following:
- •* Recent history (within the past 2 years) of autoimmune disease or syndrome
- •that required systemic treatment
- •Note: Replacement therapies which include hormone replacement (e.g., thyroid
- •hormone) or physiological doses of corticosteroids for treatment of
- •endocrinopathies (e.g., adrenal insufficiency) are not considered systemic
- •treatments.
- •* A diagnosis of immunodeficiency or administration of systemic steroids (*10
- •mg oral prednisone or equivalent) or other immunosuppressive agents within 7
- •days prior to randomization
- •Note: Physiologic doses of corticosteroids for treatment of endocrinopathies or
- •steroids with minimal systemic absorption, including topical, inhaled, or
- •intranasal corticosteroids may be continued if the participant is on a stable
- •dose. Steroids as premedication for hypersensitivity reactions (e.g., computed
- •tomography [CT] scan premedication) are permitted.
- 另有 1 项未显示
研究者
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