Clinical Trials /

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

NCT03454620

Description:

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)

Related Conditions:
  • Colorectal Carcinoma
  • Gastric Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy
  • Official Title: Phase 1b/2a Study of GC1118 in Combination With Irinotecan or FOLFIRI in Patients With Recurrent/Metastatic Solid Tumor

Clinical Trial IDs

  • ORG STUDY ID: GC1118_P12
  • NCT ID: NCT03454620

Conditions

  • Metastatic Colorectal Cancer
  • Solid Tumor

Interventions

DrugSynonymsArms
irinotecanGC1118 combination with irinotecan
FOLFIRIGC1118 combination with FOLFIRI

Purpose

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)

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
    

Trial Arms

NameTypeDescriptionInterventions
GC1118 combination with irinotecanExperimentalGC1118 weekly(3mg or 4mg) + irinotecan 180mg/m2 biweekly dosing
  • irinotecan
GC1118 combination with FOLFIRIExperimentalGC1118 weekly(3mg or 4mg) + FOLFIRI biweekly dosing
  • FOLFIRI

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limited Toxicity (DLT)
Time Frame:through study completion, approximately 5 months
Safety Issue:
Description:Profile of DLT

Secondary Outcome Measures

Measure:Tumor response according to RECIST 1.1 criteria
Time Frame:through study completion, approximately 5 months
Safety Issue:
Description:best overall response (BOR)
Measure:Tumor response according to RECIST 1.1 criteria
Time Frame:through study completion, approximately 5 months
Safety Issue:
Description:objective response rate (ORR)
Measure:Pharmacokinetics of GC1118
Time Frame:through study completion, approximately 5 months
Safety Issue:
Description:area under th curve (AUC)
Measure:Pharmacokinetics of GC1118
Time Frame:through study completion, approximately 5 months
Safety Issue:
Description:half life
Measure:Pharmacokinetics of GC1118
Time Frame:through study completion, approximately 5 months
Safety Issue:
Description:clearance
Measure:Pharmacokinetics of GC1118
Time Frame:through study completion, approximately 5 months
Safety Issue:
Description:peak serum concentration (Cmax)
Measure:Immunogenicity of GC1118
Time Frame:every odd number cycles through study completion, approximately 5 months
Safety Issue:
Description:occurrence frequency of anti-drug antibody

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Green Cross Corporation

Last Updated

April 2, 2018