Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancers
- Conditions
- Neoplasms
- Registration Number
- KCT0001463
- Lead Sponsor
- Green Cross
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
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)
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of Adverse Events;Changes in safety parameters, laboratory values, vital signs and physical examinations;Occurrence of Dose Limiting Toxicity
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Disease Control Rate (DCR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (Part B);Presence of Human Anti Drug Antibody;Time versus plasma concentration profiles and basic PK parameters of GC1118