EUCTR2016-002490-36-ES进行中（未招募）1 期
AN OPEN-LABEL, DOSE-FINDING AND PROOF OF CONCEPT STUDY OF THE PD-L1 PROBODY™ THERAPEUTIC, CX-072, AS MONOTHERAPY AND IN COMBINATION WITH YERVOY® (IPILIMUMAB) OR WITH ZELBORAF® (VEMURAFENIB) IN SUBJECTS WITH ADVANCED OR RECURRENT SOLID TUMORS OR LYMPHOMAS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 149
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
- •1. Histologically confirmed diagnosis of the following metastatic or advanced unresectable tumors that progressed on standard therapy:
- •Part A: any metastatic or advanced unresectable solid tumor or lymphoma, measurable or non-measurable disease allowed, no further standard of care therapy available
- •o Naïve to treatment with a PD-1/PD-L1 inhibitor
- •o No PD-1/PD-L1 inhibitor therapy available for their specific disease in the country where they are being treated
- •Part B1: any metastatic or advanced unresectable solid tumor or lymphoma, measurable or non-measurable disease allowed, no further standard of care therapy available
- •o Naïve to treatment with a PD-1/PD-L1 inhibitor
- •o No PD-1/PD-L1 inhibitor therapy available for their specific disease in the country where they are being treated
- •o Naïve to treatment with a CTLA-4 inhibitor
- •Part B2: any metastatic or advanced unresectable solid tumor or lymphoma with measurable disease allowed, no further standard of care therapy available
- •o Previous treatment with a PD-1/PD-L1 inhibitor
- •o Discontinued treatment with PD-1/PD-L1 inhibitor for reasons other than toxicity
- •o Naïve to treatment with a CTLA-4 inhibitor
- •o Agreement to participate in biomarker analysis and have tumor suitable for biopsy (only in cohorts receiving CX-072 + 3 mg ipilimumab [but not 10 mg ipilimumab])
- •Part C: metastatic or advanced unresectable melanoma with BRAF V600E mutation-positive as detected by a diagnostic approved test (in the region where the subject is treated), measurable or non-measurable disease allowed
- •o Naïve to treatment with BRAF-inhibitor
- •o Naïve to treatment with a PD-1/PD-L1 inhibitor
- •Part D: metastatic or advanced unresectable gastric and GEJ cancers, measurable disease required
- •o Naïve to treatment with a PD-1/PD-L1 inhibitor
- •o Subjects that have had their tumor tissue analyzed for PD-L1 may not enroll if they are known to be PD-L1 negative. (Subjects known to be PDL1 positive or that have never undergone PD-L1 tumor assessment are eligible.)
- •o HER2 negative (FISH or IHC testing acceptable)
- •o For GEJ tumors with significant esophageal component, esophageal cancer Siewert II/III
- •o Subjects must be ineligible for platinum based or fluorpyrimidine based chemotherapy or approved ramucirumab based regimen or have already received these therapies. Subjects must have had standard of care surgery for their cancer, if applicable.
- •2. Agreement to provide mandatory archival tissue or fresh biopsy. A tumor biopsy is required at baseline if there is no other record of histological diagnosis of tumor.
- •3. For subjects in Part B2 receiving 3 mg/kg of ipilimumab and those who agree to participate in the biomarker analysis and who have a tumor site that is safe to biopsy, subjects must have a biopsy within 90 days of study entry and be willing to undergo at least one on-treatment tumor biopsy.
- •4. Subjects with treated brain metastases are eligible if the brain metastases are stable and the subject does not require radiation therapy, or steroids. Active screening for brain metastases (eg, brain computed tomography [CT] or magnetic resonance imaging [MRI]) is not required.
- •5. At least 18 years of age.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •7. Anticipated life expectancy of at least 3 months.
- •8. Screening laboratory values must meet the following criteria:
- •White blood cells (WBCs) > 2000/µL or 2.0 × 10(-9)/L;
- •Neutrophils = 1500/µL or 1.5 × 10(-9)/L;
- •Platelets = 100 × 10(-3)
排除标准
- •1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
- •2. Baseline QTc is > 470 ms in the vemurafenib treatment arm, or taking any medication known to prolong the QT interval.
- •3. Prior history of myocarditis irrespective of the cause.
- •4. Treatment with strong CYP3A4 inhibitors or inducers, as well as use of CYP1A2 substrates with a narrow therapeutic window assigned to the vemurafenib treatment arm.
- •http://medicine.iupui.edu/clinpharm/ddis/main-table/
- •5. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody Tx.
- •6. Active or history of uveal, mucosal, or ocular melanoma is excluded in Parts B2 and C.
- •7. Subjects with gastrostoma are excluded in Part D.
- •8. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.
- •9. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.
- •10. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.
- •11. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
- •12. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.
- •13. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.
- •14. Unresolved acute toxicity of the NCI CTCAE v4.03 Grade > 1 (or baseline, whichever is greater) from prior anti-cancer therapy. Alopecia and other non-acute toxicities are acceptable.
- •15. History of malignancy that is active within the previous 2 years except for localized cancers that are not related to the current cancer being treated and considered to have been cured and in the opinion of the Investigator, present a low risk for recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
- •16. Received a live vaccine within 30 days prior to first dose of study drug.
- •17. Known pre-existing condition of age-related macular degeneration (AMD).
- •18. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection (including fever within 48 hours of screening), symptomatic congestive heart failure (ie, New York Heart Association Class III or IV), unstable angina pectoris, clinically significant and uncontrolled cardiac arrhythmia, non-healing wound or ulcer, or psychiatric illness/social situations that would limit compliance with study requirements.
- •19. Participating in an ongoing clinical study involving treatment with medications, radiation or surgery.
- •20. Women who are pregnant or breastfeeding.
研究者
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