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Neoplasm MetastasisPhase 1NCT02352571

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

A Phase 1 study testing GC1118 in people with Neoplasm Metastasis and Gastric Cancer, run by Green Cross Corporation at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
GC1118
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSouth Korea
Study dates
Jan 2015to Jun 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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-)
Show all 13Show fewer
  • 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)

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Ahmi Woo contact

+ 82 31 260 9467

butami@greencross.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 110-744

    Yung Jue Bang, M.D., Ph.D., bangyj@snu.ac.kr

    Yung Jue Bang, Ph.D.

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
GC1118
Medical subject headings
Neoplasm Metastasis, Stomach Neoplasms, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02352571
Study groupRoleWhat they receive
Single group assignmentExperimentalGC1118 recombinant human anti-EGFR antibody
Receives: Biological: GC1118

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Dose Limiting Toxicity (DLT)

    Measured: Approx. 6 months

  2. Frequency of Adverse Events

    Measured: Approx. 6 months

  3. 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.

    Measured: Approx. 6 months

Secondary outcomes (5)

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

    Measured: Approx. 6 months

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

    Measured: Approx. 6 months

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

    Measured: Approx. 6 months

  4. Time versus plasma concentration profiles and basic PK parameters of GC1118

    Measured: Approx. 6 months

  5. Presence of Human Anti Drug Antibody

    Assess whether participants develop an immune response to GC1118

    Measured: Approx. 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionJun 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02352571
Sponsor's protocol ID
GC1118_P1
Status last verified
Feb 2016
First submitted
21 Jan 2015
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 31164456

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GC1118 in people with Neoplasm Metastasis and Gastric Cancer, run by Green Cross Corporation at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmi Woo (+ 82 31 260 9467, butami@greencross.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Dose Limiting Toxicity (DLT) (time frame: Approx. 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02352571, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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