UnknownPhase 1

Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancer

South Korea72 participantsStarted 2015-01

Plain-language summary

The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2 Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous (IV) infusion to patients with stage IV solid tumors. The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118 and explore prognostic biomarkers and pharmacodynamic biomarkers.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Willing and able to sign a written informed consent * Nineteen (19) years of age or older * For Part A and Part C, all stage IV advanced solid cancers For Part B, stage IV of gastric cancer, colorectal cancer or other cancer * Cohort1: Metastatic CRC (K-RAS wild), No prior treatment with EGFR antibody therapeutics * Cohort2: Metastatic CRC (K-RAS wild), Progressed over EGFR antibody therapeutics * Cohort3: Advanced gastric or gastroesophageal junction cancer(EGFR++ or +++ /HER2-) * For Part A and Part C, refractory solid tumors to conventional therapy (Progressive disease during or after previous conventional therapy) * Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1 * Life expectancy of greater than or equal to 3 months * Availability of a new tumor biopsy or able to obtain unstained slides of tumor within 3 years * For Part B, at least one measurable tumor mass by RECIST v1.1 * Acceptable laboratory parameters * If all AEs caused by the previous anti-cancer therapies including surgery, chemotherapy and radiation therapy have recovered to CTCAE grade 1 or below (except alopecia) Exclusion Criteria: * Has had any major surgery or any therapy within the last 4 weeks and/or not recovered from prior therapy * Has had chemotherapy, surgery or radiotherapy within the previous 4 weeks * Confirmed brain metastases * Chronic Hepatitis C or known HIV positive patients * Liver Cirrhosis or active hepatitis B virus (HBV) c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of Dose Limiting Toxicity (DLT)

Timeframe: Approx. 6 months

Frequency of Adverse Events

Timeframe: Approx. 6 months

Changes in safety parameters, laboratory values, vital signs and physical examinations

Timeframe: Approx. 6 months

Trial details

NCT IDNCT02352571

SponsorGreen Cross Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Contact for this trial

Ahmi Woo

+ 82 31 260 9467 butami@greencross.com

View on ClinicalTrials.gov More Neoplasm Metastasis trials

Plain-language summary

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.