A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy

March 1, 2022 updated by: Green Cross Corporation

Phase 1b/2a Study of GC1118 in Combination With Irinotecan or FOLFIRI in Patients With Recurrent/Metastatic Solid Tumor

The purpose of the study is to assess the safety and tolerability of GC1118 in combination with irinotecan or FOLFIRI in order to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Phse 1b/2a, dose-finding, open-label, prospective study

This study consists of the Phase 1b part designed to determine the MTD and RP2D of GC1118 when administered in combination with irinotecan or FOLFIRI to patients with recurrent metastatic solid tumors and the Phase 2a part designed to assess the efficacy of GC1118 in combination with FOLFIRI as second-line therapy for recurrent/metastatic colorectal cancer

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chŏnam, Korea, Republic of
        • Chonnam National University Hwasun Hospital
      • Gyeonggi-do, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Korea, Republic of
        • National Cancer Center
      • Seoul, Korea, Republic of
        • Seoul Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul National Universtiy Hosipital
      • Seoul, Korea, Republic of
        • Yonsei University Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Phase 1b: Histologically or cytologically confirmed recurrent/metastatic solid cancer patients with no available standard treatment and be expected to have the anti-tumor effect with combination of GC1118 and irinotecan or GC1118 and FOLFIRI by investigator's judgement Phase 2a: Historically or cytologically confirmed, 1) EGFR-positive, KRAS/NRAS and BRAF wild type recurrent/metastatic colorectal cancer patients who failed first line chemo or targeted therapies (fluoropyrimidine-based or oxaliplatin containing chemotherapy) or whose disease were progressed within 6 months after the last dose of above mentioned treatments; Disease progression during treatment or within 6 months after completion of adjuvant/neoadjuvant chemotherapy is also considered as first line treatment failure 2) Medically documented non-HER2 overexpression (HER2 3+ or HER2+/FISH+) and EGFR 2+ or 3+ expressing recurrent/metastatic gastric cancer patients who failed (radiologically progressed) second line chemo or targeted therapies
  2. Male of female, 19 years of age or older
  3. ECOS PS 0 or 1
  4. Life expectancy of 3 months or longer
  5. Phase 2a: Presence of at least one measurable lesion according to the RECIST criteria v1.1
  6. Phase 2a: Demonstration of each cohort requirements including EGFR positive, KRAS/NRAS and BRAF wild type, EGFR 2+ or 3+ expression, and etc.
  7. Adequate bone marrow function, renal function, and hepatic function
  8. All AEs caused by previous anticancer therapies, including surgery, chemotherapy, and radiation therapy,have recovered to CTCAE grade 1 or below (except alopecia)

Exclusion Criteria:

  1. Any of the following medical histories 1) Major surgery, open biopsy, or significant traumatic injury within 4 weeks prior to the first investigational products administration or adverse events are not resolved from such procedure or injury 2) Other malignancies (exception; any of the following status are eligible) i. Disease free for 3 years or completely resected non-melanoma skin cancer ii. Successfully treated in carcinoma in situ (CIS) iii. Ta, CIS, or T1a staged superficial bladder cancer which is completely cured iv. Papillary thyroid cancer which is not being progressed without ongoing treatment v. Prostate cancer which is surgically or medically cured and is not likely to recur within 2 years
  2. Any of the following concurrent disease 1) Known brain metastasis 2) Active infection requiring systemic anti-microbial therapy 3) Human immunodeficiency virus infection or active hepatitis B or C 4) Chronic inflammatory bowel disease 5) Clinically significant interstitial lung disease or pulmonary fibrosis 6) Clinically significant hepatic disease including decompensated liver cirrhosis, etc
  3. Any of the following medication histories 1) Phase 2a recurrent/metastatic colorectal cancer: Treated with irinotecan containing regimen as first line treatment for recurrent/metastatic cancer 2) Phase 2a: Prior EGFR targeting antibody therapy 3) Received chemotherapy, immunotherapy, hormone therapy, radiotherapy within 3 weeks (within 6 weeks in case of nitrosourea or mitomycin-c) prior to first investigational products administration (In phase 2, radiotherapy within 3 weeks is not restricted unless the site is measurable lesion) 4) Ongoing or requiring the prohibited medications including immunotherapy, chemotherapy, hormone therapy, or etc. 5) Received other investigational drugs with 4 weeks prior to this investigational products adminstration
  4. Medically or psychologically inappropriate conditions for study participation by investigator's judgment
  5. Contraindication for FOLFIRI (or irinotecan) therapy
  6. Pregnant, possibly pregnant, or lactating women (Women of child bearing potential must test negative for pregnancy within 3 days prior to Cycle1 Day1
  7. Refusal to use the following appropriate contraceptives during the clinical study period and for 6 months after the last adminstration of investigational products 1) Implanted intrauterine device or intrauterine system 2) Double barrier methods (Both of condom (for mate) and diaphragm, vaginal sponge, or cervical cap (for female) should be used with spermicide) 3) Surgical sterilization (vasectomy, tubal ligation, etc.)
  8. Any other inappropriate conditions for study participation at investigator's discretion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GC1118 combination with irinotecan
GC1118 weekly(3mg or 4mg) + irinotecan 180mg/m2 biweekly dosing
Drug: irinotecan
GC1118 combination with irinotecan
Experimental: GC1118 combination with FOLFIRI
GC1118 weekly(3mg or 4mg) + FOLFIRI biweekly dosing
Drug: FOLFIRI
GC1118 combination with FOLFIRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose Limited Toxicity (DLT)
Time Frame: through study completion, approximately 5 months
Profile of DLT
through study completion, approximately 5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tumor response according to RECIST 1.1 criteria
Time Frame: before start of treatment, every 6 weeks for the duration of treatment, up to approximately 2 years.
best overall response (BOR)
before start of treatment, every 6 weeks for the duration of treatment, up to approximately 2 years.
Tumor response according to RECIST 1.1 criteria
Time Frame: before start of treatment, every 6 weeks for the duration of treatment, up to approximately 2 years.
objective response rate (ORR)
before start of treatment, every 6 weeks for the duration of treatment, up to approximately 2 years.
Pharmacokinetics of GC1118
Time Frame: through study completion, approximately 5 months
area under th curve (AUC)
through study completion, approximately 5 months
Pharmacokinetics of GC1118
Time Frame: through study completion, approximately 5 months
half life
through study completion, approximately 5 months
Pharmacokinetics of GC1118
Time Frame: through study completion, approximately 5 months
clearance
through study completion, approximately 5 months
Pharmacokinetics of GC1118
Time Frame: through study completion, approximately 5 months
peak serum concentration (Cmax)
through study completion, approximately 5 months
Immunogenicity of GC1118
Time Frame: every odd number cycles through treatment period, 28 days after the last treatment
occurrence frequency of anti-drug antibody
every odd number cycles through treatment period, 28 days after the last treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Green Cross Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yung Jue Bang, M.D.,Ph.D., Seoul National University Hosipital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 17, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GC1118_P12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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