KCT0001463招募中未知
A prospective, Open-label, Dose Escalation (Part A) and Cohort Expansion (Part B) Phase 1 Study to Investigate the Safety, Tolerability and Immunogenicity and to Determine Maximum Tolerated Dose and Recommended Phase 2 dose of GC1118 (recombinant human anti-EGFR antibody) in Patients with Advanced Solid Cancers
Green Cross0 个研究点目标入组 72 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Willing and able to sign a written informed consent
- •2. Nineteen (19) years of age or older
- •3. For Part A and Part C, all stage IV advanced solid cancers; for Part B, stage IV of gastric cancer, colorectal cancer or other cancers
- •4. For Part A and Part C, refractory solid tumors to conventional therapy (Progressive disease during or after previous conventional therapy)
- •5. Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
- •6. Life expectancy of greater than or equal to 3 months
- •7. Availability of a new tumor biopsy or able to obtain unstained slides of tumor within 3 years
- •8. For Part B, at least one measurable tumor mass by RECIST v1.1
- •9. Acceptable laboratory parameters
- •10. Recovery from surgical, chemotherapy or radiotherapy procedures (except alopecia)
排除标准
- •1. Has had any major surgery or any therapy within the last 4 weeks and/or not recovered from prior therapy
- •2. Has had chemotherapy, surgery or radiotherapy within the previous 4 weeks
- •3. Confirmed brain metastases
- •4. Chronic Hepatitis C or known HIV positive patients
- •5. Liver cirrhosis or active hepatitis B virus (HBV) carrier
- •6. Clinically significant interstitial pulmonary disease
- •7. Has received prior treatment with cetuximab or anti-EGFR antibody therapy is not permitted in Part B(however, allowed in Part A and Part C)
- •8. Clinically significant cardiac disease or impaired cardiac function
- •9. Acute or subacute interstinal obstruction or inflammatory bowel disease
- •10. Has had immunotherapy, chemotherapy or hormonal therapy prohibited as per study protocol
- •11. Has participated in any study using an investigational drug during the previous 4 weeks
- •12. Known hypersensitivity to the study drug
- •13. History of second primary malignancy within 3 years prior to starting study treatment (excluding early gastric cancer, early thyroid cancer, cervical cancer stage 0 or skin cancer)
- •14. Severe renal impairment (drug dependence) within 6 months or patients receiving dialysis
- •15. Severe hepatic impairment
- •16. Current active infection
- •17. Known KRAS-mutation for Part A and Part C, Known KRAS-mutation for Part B or BRAF matant
- •18. Medical or psychiatric illness that, in the opinion of the investigator, may affect compliance with scheduled visits
- •19. Pregnant (potentially) or lactating women
- •20. Patients refuse to use acceptable forms of contraceptions from the time of consent through six months after the study drug administration
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