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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352571
Recruitment Status : Unknown
Verified February 2016 by Green Cross Corporation.
Recruitment status was:  Recruiting
First Posted : February 2, 2015
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief 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.


Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Gastric Cancer Colorectal Cancer Biological: GC1118 Phase 1

Detailed Description:

An open-label, single-arm, multi-center, phase 1, dose-escalation study will be conducted to define the MTD/RP2D, safety, PK, immunogenicity and antitumor activity of GC1118 in patients with refractory disease for whom no standard therapy is available.

This study is in three parts: a dose escalation segment (Part A), a cohort expansion (Part B) and biweekly administration(Part C). In part A, a dose escalation schema will be applied in dose level cohorts. GC1118 will be administered weekly on Study Day 1, 8, 15, and 22 of each 28-day cycle by IV infusion. Dose escalation may occur as described in the study protocol. Once the MTD has been established during Part A, the MTD cohort will be expanded in part B. And GC1118 will be administered biweekly on Study Day 1, 15 each 28-day cycle by IV infusion in part C.

Study assessments will include AE monitoring including physical examination, vital signs and clinical laboratory tests, ECG monitoring, PK analysis of serum GC1118, an assessment of potential anti-GC1118 antibody response and an exploration of potential prognostic and pharmacodynamic biomarkers.

Tumor response assessments using Study Day 36 CT/MRI scans will be performed approximately five weeks after the first GC1118 dose for each patient (Part A only). Patients with evidence of disease regression (partial or complete response or stable disease by RECIST criteria) will be allowed to continue therapy at the same dose. Subsequent cycles will consist of administration of GC1118 on Day 1, 8, 15, and 22 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part A,B and Day 1, 15 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part C.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single group assignment
GC1118 recombinant human anti-EGFR antibody
Biological: GC1118

For Part A, GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in the dose escalation cohorts, starting 0.3mg/kg until Maximum Tolerated Dose is defined.

For Part B, the defined MTD/RP2D of GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in patients with stage IV of gastric cancer, colorectal cancer or other cancers.

For Part C, GC1118 will be administered by IV infusion once every 2 weeks for 4 weeks (28-day cycles) in patients with all stage IV advanced solid cancers.

Part A, Part B and Part C participants who qualify for subsequent cycles will receive continued GC1118 until evidence of progression of disease.





Primary Outcome Measures :
  1. Occurrence of Dose Limiting Toxicity (DLT) [ Time Frame: Approx. 6 months ]
  2. Frequency of Adverse Events [ Time Frame: Approx. 6 months ]
  3. Changes in safety parameters, laboratory values, vital signs and physical examinations [ Time Frame: Approx. 6 months ]
    Vital sign assessment will include systolic and diastolic blood pressure, heart rate, respiration rate and temperature. Laboratory values will include hematology and clinical chemistry.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 [ Time Frame: Approx. 6 months ]
  2. Disease Control Rate (DCR) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 [ Time Frame: Approx. 6 months ]
  3. Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 (Part B) [ Time Frame: Approx. 6 months ]
  4. Time versus plasma concentration profiles and basic PK parameters of GC1118 [ Time Frame: Approx. 6 months ]
  5. Presence of Human Anti Drug Antibody [ Time Frame: Approx. 6 months ]
    Assess whether participants develop an immune response to GC1118



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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) carrier
  • Clinically significant interstitial pulmonary disease
  • 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)
  • Clinically significant cardiac disease or impaired cardiac function
  • Acute or subacute intestinal obstruction or Inflammatory bowel disease
  • Has had immunotherapy, chemotherapy or hormonal therapy prohibited as per study protocol
  • Has participated in any study using an investigational drug during the previous 4 weeks
  • Known hypersensitivity to the study drug
  • History of second primary malignancy within 3 years prior to starting study treatment (excluding early gastric cancer, thyroid cancer, cervical cancer or skin cancer)
  • Severe renal impairment
  • Severe hepatic impairment
  • Current active infection
  • Known KRAS-mutation for Part A and Part C, Known KRAS-mutation for Part B or BRAF matant
  • Medical or psychiatric illness that, in the opinion of the investigator, may affect compliance with scheduled visits
  • Pregnant (potentially fertile patients) or lactating women
  • Patients refuse to use acceptable forms of contraceptions from the time of consent through six months after the study drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352571


Contacts
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Contact: Ahmi Woo + 82 31 260 9467 butami@greencross.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Yung Jue Bang, M.D., Ph.D.       bangyj@snu.ac.kr   
Principal Investigator: Yung Jue Bang, Ph.D.         
Sponsors and Collaborators
Green Cross Corporation
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02352571    
Other Study ID Numbers: GC1118_P1
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes