EUCTR2018-000618-39-ES进行中（未招募）1 期
A Phase 2, Randomized, Open-Label, Multicenter, Three-Arm Trial of Sym004 versus each of its Component Monoclonal Antibodies, Futuximab and Modotuximab, in Patients with Chemotherapy-Refractory Metastatic Colorectal Carcinoma and Acquired Resistance to Anti-EGFR Monoclonal Antibody Therapy - Sym004 versus Futuximab or Modotuximab in Patients with mCRC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
入选标准
- •1. Male or female patients, = 18 years of age at the time of obtaining informed consent
- •2. Patients with histologically- or cytologically-confirmed mCRC
- •3. Patients with MSI-H/dMMR tumors must have received prior therapy with pembrolizumab, nivolumab, or other PD-1/PD-L1 pathway blocker and must have progressed on that therapy.
- •4. Patients meeting the protocol definition of TNmCRC assessed by screening blood test (ctDNA):
- •a. Without RAS (KRAS and NRAS) MAF = 20% for mutations in the following codons:
- •? Exon 2: codon 12, 13
- •? Exon 3: codon 59, 61
- •? Exon 4: codon 117, 146
- •b. Without BRAF V600E mutation at any MAF
- •c. Without EGFR-ECD V441D, V441G, S464L, G465E, G465R, S492R mutations at any MAF
- •5. Patients with mCRC currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor
- •6. Patients with measurable disease according to RECIST v1.1 (Appendix 5), and willingness to undergo a total of 2 biopsies of a primary or metastatic tumor site(s) considered safely accessible for biopsy
- •7. Patients must have received at least 2 prior regimens of standard chemotherapy for mCRC and must have been refractory to or failed (includes intolerance to) those regimens. Prior standard chemotherapy may not have included TAS-102 or regorafenib, but must have included all of the following agents (where approved in the country):
- •a. Fluoropyrimidines, irinotecan, and oxaliplatin
- •b. An anti-vascular endothelial growth factor (VEGF) pathway inhibitor approved for treatment of mCRC
- •c. At least one anti-EGFR mAb approved for treatment of mCRC
- •8. Patients with acquired” resistance to commercially available anti-EGFR mAbs approved for the treatment of mCRC. Patients must have:
- •a. Received treatment with an anti-EGFR for >16 weeks
- •b. PD documented by imaging or clinical findings < 6 calendar months after cessation of previous anti-EGFR mAb treatment
- •c. No more than 6 calendar months from last dose of previous anti-EGFR mAb treatment to date of consent for this trial (regardless of the line of therapy in which it was used)
- •9. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (or equivalent Karnofsky PS)
- •10. Patients, male and female, who are either not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 3 months after the last dose of IMP.
- •11. Must have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this 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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •1. Women who are pregnant or lactating or intending to become pregnant before, during, or within 3 months after the last dose of IMP. WOCBP, and fertile men with WOCBP partner (s) not using and not willing to use a highly effective method of contraception.
- •2. Patients with a prior history any of the following mutations in their tumor at the time of any previous assessment:
- •a. RAS (KRAS and NRAS) mutations in the following codons:
- •? Exon 2: codon 12, 13
- •? Exon 3: codon 59, 61
- •? Exon 4: codon 117, 146
- •b. BRAF V600E mutation
- •c. EGFR-ECD V441D, V441G, S464L, G465E, G465R, S492R mutations
- •3. Patients with known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required
- •4. Patients with an active second malignancy or history of another malignancy within the last 5 years with the exception of:
- •a. Treated non-melanoma skin cancers
- •b. Treated carcinoma in situ (e.g., breast, cervix, endometrium) provided CR was achieved at least 5 years prior to study and no additional therapy is ongoing or required during study period)
- •c. Controlled, superficial carcinoma of the bladder
- •d. T1a carcinoma of the prostate comprising < 5% of resected tissue and prostate specific antigen (PSA) within normal limits (WNL) since resection
- •5. Patients with any of the following hematologic abnormalities at baseline*:
- •a. Hemoglobin < 9.0 g/dL
- •b. Absolute neutrophil count (ANC) < 1,500 per mm3
- •c. Platelet count < 100,000 per mm3
- •6. Patients with any of the following serum chemistry abnormalities at baseline:
- •a. Total bilirubin > 2.0 × the upper limit of normal (ULN) for the institution
- •b. Alkaline phosphatase (ALP) > 2.5 × the ULN for the institution (> 5 × ULN if due to hepatic involvement by tumor)
- •c. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × the ULN for the institution (> 5 × ULN if due to hepatic involvement by tumor)
- •d. Creatinine clearance (CrCl) < 30 mL/min as calculated by the Cockroft-Gault formula
- •e. Magnesium < 1.2 mg/dL
- •7. Patients with:
- •a. Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE), within 4 weeks prior to first administration of IMP, unless adequately treated and considered by the Investigator to be stable
- •b. Active uncontrolled bleeding or a known bleeding diathesis
- •8. Patients with a known clinically significant cardiovascular disease or condition, including:
- •a. Need for antiarrhythmic medical therapy for a ventricular arrhythmia or other uncontrolled arrhythmia (patients with controlled atrial fibrillation (heart rate <90) for > 30 days prior to study entry are eligible)
- •b. Severe conduction disturbance (e.g., 3rd degree heart block)
- •c. HR-corrected QT interval (QTc interval) = 480 msec (as calculated by Bazet’s formula)
- •d. Uncontrolled hypertension (per the Investigator’s discre
研究者
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