EUCTR2021-000707-20-PL进行中（未招募）1 期
A Phase 1/2a Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of AFM24 in Combination with Atezolizumab in Patients with Selected Advanced/Metastatic EGFR-expressing Cancers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Affimed GmbH
- 入组人数
- 148
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
- 性别
- All
入选标准
- •1) Voluntary provision and understanding of signed and dated, written informed consent prior to any mandatory study-specific procedures, sampling, or analysis.
- •2) Patients must be aged =18 years on the day of signing informed consent (or of an acceptable age according to local regulations, whichever is older).
- •3) Patients must have documented radiological progression during or after their latest therapy for all phases.
- •4) Patients have documented histologically or cytologically confirmed advanced or metastatic EGFR-positive (positive staining for EGFR in =1% of tumor cells determined by a locally validated immunohistochemistry assay) select cancer types, except for NSCLC
- •patients (cohorts EXP-1 and EXP-4), and meet the following criteria:
- •Dose Escalation Phase (Phase 1):
- •Dose Escalation Cohorts: Patients who meet the criteria specified for the expansion cohorts.
- •Expansion phase (Phase 2a):
- •-EXP-1: patients with advanced or metastatic, EGFR WT expressing NSCLC whose disease has progressed after having received =1 prior lines of therapy for advanced disease.
- •-EXP-2: patients with locally advanced, unresectable, or metastatic gastric or GEJ adenocarcinoma refractory to or, intolerant of, standard therapy.
- •-EXP-3: patients with advanced or metastatic hepatocellular carcinoma (other than fibrolamellar and sarcomatoid subtype; Barcelona Clinic Liver Cancer Stage C disease or Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy), hepatobiliary-, or pancreatic adenocarcinoma. Archived paraffin-embedded tumor tissue is acceptable for EGFR determination, otherwise a fresh tumor biopsy must be performed.
- •-EXP-4: patients with advanced or metastatic NSCLC harboring a targetable EGFR kinase domain mutation and whose disease has progressed on or after having received =1 prior lines of therapy for advanced disease including =1 prior TKI approved for EGFR mutated NSCLC, such as gefitinib, erlotinib, afatinib, dacomitinib or osimertinib.
- •5) ECOG Performance Status (PS) 0 or 1
- •6) Adequate organ function as determined by:
- •a. Hematological
- •i. Absolute neutrophil count (ANC) =1.5×10^9/L (1,500/mm3)
- •ii. Platelet count =75×10^9/L (75,000/mm3)
- •iii. Hemoglobin = 9 g/dL.
- •b. Hepatic: Total bilirubin =1.5 × ULN or =3 × ULN in participants with Gilbert's syndrome, ALT and AST =2.5×ULN for patients without liver metastasis and ALT and AST =5×ULN for patients with liver metastasis or hepatocellular carcinoma (HCC). Albumin >3.0 g/dL. For HCC, Child-Pugh score <7 (Child-Pugh Class A) (APPENDIX H for details for the Child-Pugh Score classification).
- •c. Renal: Serum creatinine =1.5 × ULN OR Measured or calculated creatinine clearance = 60 mL/min for patients with creatinine levels > 1.5 × institutional ULN.
- •d. INR or PT or aPTT = 1.5 × ULN unless patient is receiving anticoagulant therapy, in which case PT/aPTT must be within therapeutic range for intended use of anticoagulants.
- •Note: no growth factor or transfusion support within 7 days of testing allowed; and patients must be reassessed on or within 7 days of the first AFM24 infusion [i.e., Day -7] to remain eligible
- •7) Serum potassium, calcium, magnesium, and phosphate within normal limits or not worse than CTCAE v5.0 Grade 1 and asymptomatic.
- •8) Patients with inactive/asymptomatic carrier, chronic, or active hepatitis B virus (HBV) infection must meet the following criteria: HBV deoxyribonucleic acid (DNA) <500 IU/mL (or 2500 copies/mL) at screening.
- •Patients with cured h
排除标准
- •1) Currently receiving active treatment in any other clinical study, or administration of other investigational agent.
- •2) Treatment with any systemic anticancer therapy including investigational agent within 4 weeks of the first dose of the study drug, 6 weeks for mitomycin C or nitrosoureas, 2 weeks (or 5 half-lives whichever is longer) for using fluorouracil or small molecule targeted drugs, 2 weeks for using traditional Chinese medicine with anti-tumor indication. Anticancer therapies include cytotoxic chemotherapy, targeted inhibitors, and immunotherapies, but do not include hormonal therapy or radiotherapy for bone metastases >2 weeks prior to first AFM24 infusion (i.e.,Day-7).
- •3) Radiation therapy within 4 weeks before first dose of study drug (with the exception of limited palliative radiotherapy) or unresolved (CTCAE v5.0 >Grade 1) toxicity from previous radiotherapy (e.g. radiation dermatitis).
- •4) Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day -7 or anticipation of need for a major surgical procedure during the course of the study.
- •5) Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days prior to first AFM24 infusion (i.e. D-7).
- •6) Patients with toxicities (because of prior anticancer therapy) which have not recovered to baseline or CTCAE v5.0 = Grade 1, except for AEs not considered a likely safety risk (e.g. alopecia, neuropathy, specific laboratory abnormalities).
- •7) History of interstitial lung disease, or non-infectious pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening.
- •8) History of any other invasive malignancy, unless previously treated with curative intent and the patient has been disease free for 3 years or longer. Acceptable previous malignancies include completely removed in situ cervical intra-epithelial neoplasia, non-melanoma skin cancer, ductal carcinoma in situ, and early-stage prostate cancer that has been adequately treated.
- •9) Untreated or symptomatic central nervous system metastases including leptomeningeal disease or spinal cord compression.
- •10) One or more of the following cardiac criteria:
- •a. Unstable angina;
- •b. Myocardial infarction within 6 months prior to screening;
- •c. NYHA Class III and IV heart failure;
- •d. Corrected QT interval >470 msec obtained as the mean from 3 consecutive resting ECGs using the Fridericia’s formula;
- •e. Clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;
- •f. Congenital long QT syndrome;
- •g. Uncontrolled hypertension despite maximum antihypertensive therapy.
- •11) Stroke or transient ischemic attack within 6 months prior to screening.
- •12) Has received a live vaccine administered within 28 days of planned treatment start (i.e. Day -7) or while participating in the study.
- •13) Diagnosis of immunodeficiency or active infection including known HBV, HCV, or HIV.
- •14) A known history or autoimmune disease requiring systemic immunosuppressive therapy; or any disease process requiring systemic immunosuppressive therapy (such as high-dose steroids defined as =10 mg prednisone or equivalent per day) within 4 weeks prior to the first
- •dose of AFM24.
- •Exceptions:
- •-Topical (=20% of the skin surface area), ocular, intra-articular, intranasal, or inhalation
研究者
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