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

NCT03454620 | Completed Phase 1 DMC

• 1 other identifier: GC1118_P12
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 6

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)

Conditions

Metastatic Colorectal Cancer; Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Dose Limited Toxicity (DLT)

  Profile of DLT

  through study completion, approximately 5 months

Secondary Outcomes (7)

• Tumor response according to RECIST 1.1 criteria

  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

  before start of treatment, every 6 weeks for the duration of treatment, up to approximately 2 years.

• Pharmacokinetics of GC1118

  through study completion, approximately 5 months

• Pharmacokinetics of GC1118

  through study completion, approximately 5 months

• Pharmacokinetics of GC1118

  through study completion, approximately 5 months

Study Arms (2)

GC1118 combination with irinotecan

EXPERIMENTAL

GC1118 weekly(3mg or 4mg) + irinotecan 180mg/m2 biweekly dosing

Drug: irinotecan

GC1118 combination with FOLFIRI

EXPERIMENTAL

GC1118 weekly(3mg or 4mg) + FOLFIRI biweekly dosing

Drug: FOLFIRI

Interventions

irinotecan DRUG

GC1118 combination with irinotecan

GC1118 combination with irinotecan

FOLFIRI DRUG

GC1118 combination with FOLFIRI

GC1118 combination with FOLFIRI

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male of female, 19 years of age or older
• ECOS PS 0 or 1
• Life expectancy of 3 months or longer
• Phase 2a: Presence of at least one measurable lesion according to the RECIST criteria v1.1
• Phase 2a: Demonstration of each cohort requirements including EGFR positive, KRAS/NRAS and BRAF wild type, EGFR 2+ or 3+ expression, and etc.
• Adequate bone marrow function, renal function, and hepatic function
• All AEs caused by previous anticancer therapies, including surgery, chemotherapy, and radiation therapy,have recovered to CTCAE grade 1 or below (except alopecia)

You may not qualify if:

• 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
• 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
• 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
• Medically or psychologically inappropriate conditions for study participation by investigator's judgment
• Contraindication for FOLFIRI (or irinotecan) therapy
• Pregnant, possibly pregnant, or lactating women (Women of child bearing potential must test negative for pregnancy within 3 days prior to Cycle1 Day1
• 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.)
• Any other inappropriate conditions for study participation at investigator's discretion

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (6)

National Cancer Center

Gyeonggi-do, South Korea

Location

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Location

Chonnam National University Hwasun Hospital

Jeonam, South Korea

Location

Seoul Asan Medical Center

Seoul, South Korea

Location

Seoul National Universtiy Hosipital

Seoul, South Korea

Location

Yonsei University Health Care System

Seoul, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Yung Jue Bang, M.D.,Ph.D.

  Seoul National University Hosipital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 6, 2018
• Study Start: April 2, 2018
• Primary Completion: September 17, 2021
• Study Completion: January 10, 2022
• Last Updated: March 3, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)