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

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ClinicalTrials.gov Identifier: NCT03454620
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Solid Tumor Drug: irinotecan Drug: FOLFIRI Phase 1 Phase 2

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b/2a Study of GC1118 in Combination With Irinotecan or FOLFIRI in Patients With Recurrent/Metastatic Solid Tumor
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Dose Limited Toxicity (DLT) [ Time Frame: through study completion, approximately 5 months ]
    Profile of DLT


Secondary Outcome Measures :
  1. Tumor response according to RECIST 1.1 criteria [ Time Frame: through study completion, approximately 5 months ]
    best overall response (BOR)

  2. Tumor response according to RECIST 1.1 criteria [ Time Frame: through study completion, approximately 5 months ]
    objective response rate (ORR)

  3. Pharmacokinetics of GC1118 [ Time Frame: through study completion, approximately 5 months ]
    area under th curve (AUC)

  4. Pharmacokinetics of GC1118 [ Time Frame: through study completion, approximately 5 months ]
    half life

  5. Pharmacokinetics of GC1118 [ Time Frame: through study completion, approximately 5 months ]
    clearance

  6. Pharmacokinetics of GC1118 [ Time Frame: through study completion, approximately 5 months ]
    peak serum concentration (Cmax)

  7. Immunogenicity of GC1118 [ Time Frame: every odd number cycles through study completion, approximately 5 months ]
    occurrence frequency of anti-drug antibody



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:

  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 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

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): NCT03454620


Contacts
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Contact: Jung Woo Choi +82 31 260 9092 i204409@greencross.com

Locations
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Korea, Republic of
Seoul National Universtiy Hosipital Recruiting
Seoul, Korea, Republic of
Contact: Yung Jue Bang, .M.D., Ph.D.         
Principal Investigator: Yung Jue Bang, M.D., Ph.D.         
Sponsors and Collaborators
Green Cross Corporation
Investigators
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Principal Investigator: Yung Jue Bang, M.D.,Ph.D. Seoul National University Hosipital

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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT03454620     History of Changes
Other Study ID Numbers: GC1118_P12
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents