NL-OMON47426已完成不适用
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 - PROCLAIM-001
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 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 64（—）
入选标准
- •All pts must have histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors that progressed or are intolerant to standard therapy.
- •Inclusion criteria for subjects in each specific Part: ;• Part A: any metastatic or advanced unresectable solid tumor or lymphoma, measurable or nonmeasurable disease allowed, no further SOC therapy available;
- •o Immunotherapy naive, including PD-1/PD-L1 and CTLA-4 inhibitor therapy naive (where there is no immunotherapy or PD-1/PD-L1 and CTLA-4 inhibitor therapy available for their specific disease in the country where they are being treated); and
- •o Subjects participating in the imaging substudy must meet both main study and substudy entry criteria to be enrolled in the study; ;• Part A2: any metastatic or advanced unresectable solid tumor or lymphoma (at least 2 subjects in each cohort with thymic epithelial tumor, thymoma, or thymic carcinoma), measurable disease allowed, no further SOC therapy available;
- •o TPS >= 1% membranous staining based on the DAKO PD-L1 IHC 22C3 pharmDx;
- •o Immunotherapy naive, including PD-1/PD-L1 and CTLA-4 inhibitor therapy naive (where there is no immunotherapy or PD-1/PD-L1 and CTLA-4 inhibitor therapy
- •available for their specific disease in the country where they are being treated); and
- •o Agreement to participate in biomarker analysis and have a tumor site that is safe to biopsy; ;• Part B1: any metastatic or advanced unresectable solid tumor or lymphoma (excluding thymic epithelial tumor, thymoma, or thymic carcinoma), measurable or nonmeasurable disease allowed, no further SOC therapy available;
- •o Immunotherapy naive, including PD-1/PD-L1 and CTLA-4 inhibitor therapy naive (where there is no immunotherapy or PD-1/PD-L1 and CTLA-4 inhibitor therapy available for their specific disease in the country where they are being treated); ;• Part B2: any metastatic or advanced unresectable solid tumor or lymphoma (excluding thymic epithelial tumor, thymoma, or thymic carcinoma) with measurable disease allowed, no further SOC 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 Naive to treatment with a CTLA-4 inhibitor; and
- •o Agreement to participate in biomarker analysis and have a tumor site that is safe to biopsy (only in cohorts receiving CX-072 + 3 mg/kg ipilimumab [but not 6 or
- •10 mg/kg 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
- •pt is treated), measurable or nonmeasurable disease allowed;
- •o Naive to treatment with BRAF-inhibitor; and
- •o Immunotherapy naive, including PD-1/PD-L1 and CTLA-4 inhibitor therapy naive ;• Part D: measurable disease is required;
- •* Must be willing to provide a blood sample at Screening for hTMB testing; and
- •* Immunotherapy naive, including PD-1/PD-L1 and CTLA-4 inhibitor therapy naive (where there is no available life-prolonging immunotherapy or PD-1/PD-L1 and CTLA-4 inhibitor therapy to the pt available for their specific disease in the country where they are being treated) of the following tumor types:
- •* Metastatic or advanced unresectable UPS;
- •* TPS >= 1% membranous staining or unknown PD-L1 status; and
- •* Subjects must have had SOC surgery and/or radiation for their UPS; subjects with metastatic
排除标准
- •1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen;;2. Baseline QTc is > 470 ms or taking any medication known to prolong the QT interval; ;3. Prior history of myocarditis irrespective of the cause;;4. Treatment with strong cytochrome P450 (CYP) 3A4 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 mAb therapy or known hypersensitivity to any Probody therapeutic; ;6. Active or history of uveal, mucosal, or ocular melanoma is excluded in Parts B2 and C;;7. History of interstitial lung disease for patients with TET are excluded in Part B1 and B2.;8. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, acute or chronic hepatitis B or C; patients with HIV that have an undetectable viral load and a CD4 cell count > 400/mL and who remain on antiretroviral regimen will be eligible for enrollment into anal SCC cohorts in Parts D and E and hTMB cohorts cohorts in Part D; ;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, type 1 insulin dependent diabetes mellitus or myasthenia gravis. ;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 within 14 days prior to receiving study drug; radiation therapy within 3 months prior to receiving study medication (except for radiotherapy for the purposes of palliation confined to a single field that is not the target lesion). ;13. Patients in Part C cannot have a glomerular filtration rate < 60mL/min/1.73 m2;;14. 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; 15. Unresolved acute toxicity of the NCI CTCAE v4.03 Grade > 1 (or baseline, whichever is greater) from prior anti-cancer therapy. Alopecia and other nonacute toxicities are acceptable; ;16. 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; ;17. Received a live vaccine within 30 days prior to first dose of study drug;;18. Known pre-existing condition of age-related macular degeneration;;19. Intercurrent illness, including, but not limited to, symptomatic congestive heart failure (i.e., New York Heart Association Class III or IV), unstable angina pectoris, clinically significant and uncontrolled cardiac arrhythmia, nonhealing wound or ulcer, or psychiatric illness/social situations that would limit compliance with study requireme
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