CTIS2024-511999-32-00招募中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 - AFM24-102
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 年龄范围
- 18 至 65+（—）
- 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., 10. Female patients of childbearing potential must have a negative urine or serum pregnancy test at Screening and prior to first AFM24 infusion (i.e., Day -7) to be eligible in this study., 11. Females of childbearing potential must agree to sexual abstinence or be willing to use a highly effective method of contraception for the course of the study from 14 days prior to the first dose of study drug through 5 months after the last dose of study drug., 12. Males who have female partners of childbearing potential must agree to use a highly effective method of contraception starting with the first dose of study therapy through 5 months after the last dose of study drug., 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. -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. Archived paraffin embedded tumor tissue is acceptable for EGFR determination, otherwise a fresh tumor biopsy must be performed., 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 =75×109/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). 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
排除标准
- •1. Currently receiving active treatment in any other clinical study, or administration of other investigational agent., 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 corticosteroids with minimal systemic absorption -Short Course (=7 days) of corticosteroids prescribed prophylactically or for treatment of a non-autoimmune causes -Physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, 15. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with 14 days before the first dose of study treatment (i.e. Day -7) through 5 months after the last dose of AFM24., 16. Patient's unwillingness to comply with the protocol or inability to appreciate the nature, meaning, and consequences of the study and to formulate his/her own wishes correspondingly., 17. Known hypersensitivity to monoclonal antibodies or any components used in the AFM24 or atezolizumab drug product preparations and any history of anaphylaxis; or uncontrolled asthma., 18. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic antibacterial, antifungal, or antiviral 2 weeks before the first dose of AFM24 infusion (on Day -7), decompensated cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements., 19. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate., 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
研究者
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