A Phase 2, Open-Label, Multi-cohort Study of PD-L1 Probody™ Therapeutic CX-072 in Combination With Other Anticancer Therapy in Adults With Solid Tumors(PROCLAIM-CX-072-002) - PROCLAIM -CX-072-002

CytomX Therapeutics, Inc0 个研究点目标入组 170 人开始时间: 2019年8月15日最近更新: 2020年11月16日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: CytomX Therapeutics, Inc
入组人数: 170

研究概览入排标准研究者记录与标识符相似试验

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. At least 18 years of age
•2. Measurable disease as defined by RECIST v1.1
•3. Eastern Cooperative Oncology Group (ECOG) performance status of =1
•4. Agree to provide tumor tissue and blood samples for biomarker assessment
•Part A: Must agree to provide mandatory archival tumor tissue (formalin-fixed paraffin embedded tumor block or unstained slides) or undergo a new tumor biopsy
•Part B: Must agree to provide tumor tissue from the initial diagnostic biopsy and prospectively agree to provide tumor tissue obtained from surgery on study for pathologic analysis and for biomarker assessment
•5. Subjects with treated brain metastases are eligible if the brain metastases are stable (no magnetic resonance imaging [MRI] evidence of progression for at least 8 weeks after treatment is complete and within 28 days prior to first dose of study treatment) and the subject does not require radiation therapy or steroids. Active screening for brain metastases (eg, brain computed tomography [CT] or MRI) is not required
•6. Screening laboratory values must meet all of the following criteria:
•White blood cells >2000/µL or 2.0 × 10 to the power of 9/L
•Neutrophils =1500/µL or 1.5 × 10 to the power of 9/L
•Platelets =100 × 10 to the power of 3/µL or 100 × 10 to the power of 9/L
•Hemoglobin =9.0 g/dL (may have been transfused) or 90.0 g/L
•Creatinine =2 mg/dL or 176.8 µmol/L OR measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or creatinine clearance) >50 mL/min
•AST and ALT =2.5 × upper limit of normal (ULN)
•Total bilirubin within ULN (unless diagnosed with Gilbert’s syndrome, those subjects must have a total bilirubin <3.0 mg/dL or 51.3 µmol/L)
•Amylase and lipase =1.5 × ULN
•International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =1.5 × ULN (unless subject is on therapeutic anticoagulation, at which time the INR and aPTT must be in the target therapeutic anticoagulation range)
•Serum albumin =2.5 g/dL
•7. Females of childbearing potential and nonsterile males must agree to practice highly effective methods of birth control (as described in Appendix C) for the duration of the study and for 6 months after the last dose of study treatment
•8. The ability to understand and the willingness to sign a written ICF and adhere to study schedule and prohibitions
•See additional cohort-specific inclusion criteria in Sections 4.2, 4.3, 4.4, and 4.5 of the Protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 80

排除标准

•1. Treatment with cytotoxic chemotherapy, biologic agents, radiation, immunotherapy, or any investigational agent within 28 days prior to the first dose of study tr. This interval can be reduced to 2 weeks for subjects who received bone-only radiation therapy or for subjects whose most recent prior therapy was a single-agent, small-molecule kinase inhibitor having a half-life of 3 days or less.
•- For Cohort A2: Prior anti-PD-1/PD-L1 antibody given as a single agent is not excluded within the 28 days prior to the first dose of study treatment. Time from last dose of prior anti-PD-1/PD-L1 inhibitor to first dose of study treatment must be at least the same length as the time interval of the prior PD-1/PD-L1 dosing schedule (eg, if prior PD-1/PD-L1 dosing was once every 14 days, then the last dose must have been at least 14 days prior to first dose of study tr)
•2. Prior therapy with a chimeric antigen receptor T cell–containing regimen
•3. History of active autoimmune disease(s) 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
•4. History of myocarditis regardless of the cause
•5. History of intolerance to prior checkpoint inhibitor therapy defined as the need to discontinue treatment due to an irAE
•6. History of toxic epidermal necrolysis or Stevens-Johnson syndrome
•7. History of any syndrome or medical condition that required treatment with systemic steroids (=10 mg daily prednisone equivalents) or immunosuppressive medications. However, subjects who required brief courses of steroids (eg, as prophylaxis for IV contrastor for treatment of an allergic reaction) may be eligible with Sponsor approval. Inhaled or topical steroids are permitted.
•8. Baseline corrected QT interval (QTc) >470 ms. If a subject starts on a QTc prolonging drug(s), a series of electrocardiograms (ECGs) should be obtained to redefine the baseline QTc.
•9. Unresolved acute toxicity CTCAE v5.0 Grade =1 (or baseline, whichever is greater) from prior anticancer therapy. Alopecia and other nonacute toxicities are acceptable.
•10. History of severe allergic or anaphylactic reactions to human mAb therapy or known hypersensitivity to any Probody therapeutic
•11. Subjects with known human immunodeficiency virus, acquired immune deficiency syndrome, or any related illness
•12. Subjects with acute or chronic hepatitis B or C
•13. History of allogeneic tissue/solid organ transplant, stem cell transplant, or bone marrow transplant
•14. Major surgery (eg, that required general anesthesia) within 4 weeks prior to the first dose of study treatment (and must be confirmed to be completely healed), or minor surgery (eg, not
•involving chest, abdomen, or intracranial structures) or gamma knife treatment (with adequate healing) within 14 days prior to first dose of study treatment (excluding biopsies conducted with local/topical anesthesia) if complete healing is confirmed
•15. History of active malignancy not related to the cancer being treated within the previous 2 years, with the exception of localized cancers that are considered 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, and carcinoma in situ of the pr

研究者

发起方

CytomX Therapeutics, Inc

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