NL-OMON49159已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
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
- •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
- •* 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
- •* 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
- •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.
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 treatment. 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 treatment)
- •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. Hormone deficiency due to prior anticancer therapy that is
- •deemed stable with supplementation or does not require supplementation is
- •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
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