NCT02352571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 6, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

January 21, 2015

Last Update Submit

July 4, 2016

Conditions

Neoplasm MetastasisGastric CancerColorectal Cancer

Outcome Measures

Primary Outcomes (3)

  • Occurrence of Dose Limiting Toxicity (DLT)

    Approx. 6 months

  • Frequency of Adverse Events

    Approx. 6 months

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

    Vital sign assessment will include systolic and diastolic blood pressure, heart rate, respiration rate and temperature. Laboratory values will include hematology and clinical chemistry.

    Approx. 6 months

Secondary Outcomes (5)

  • Overall Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    Approx. 6 months

  • Disease Control Rate (DCR) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1

    Approx. 6 months

  • Progression-Free Survival (PFS) as per Response Evaluation Criteria in Solid Tumors(RECIST) v1.1 (Part B)

    Approx. 6 months

  • Time versus plasma concentration profiles and basic PK parameters of GC1118

    Approx. 6 months

  • Presence of Human Anti Drug Antibody

    Approx. 6 months

Study Arms (1)

Single group assignment

EXPERIMENTAL

GC1118 recombinant human anti-EGFR antibody

Biological: GC1118

Interventions

GC1118BIOLOGICAL

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.

Single group assignment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

Related Publications (1)

  • Oh DY, Lee KW, Han SW, Kim JW, Shin JW, Jo SJ, Won J, Hahn S, Lee H, Kim WH, Bang YJ. A First-in-Human Phase I Study of GC1118, a Novel Anti-Epidermal Growth Factor Receptor Antibody, in Patients with Advanced Solid Tumors. Oncologist. 2019 Aug;24(8):1037-e636. doi: 10.1634/theoncologist.2019-0294. Epub 2019 Jun 4.

    PMID: 31164456DERIVED

MeSH Terms

Conditions

Neoplasm MetastasisStomach NeoplasmsColorectal Neoplasms

Interventions

GC1118

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Ahmi Woo

CONTACT

+ 82 31 260 9467butami@greencross.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 2, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

July 6, 2016

Record last verified: 2016-02

Locations

KR(1)