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    DRUG:

    GC-1118A

    i
    Other names: GC-1118A, GC-1118, GC1118, GC 1118, GC1118A
    Company:
    GC Biopharma
    Drug class:
    EGFR inhibitor
    Related drugs:
    11ms
    A Phase 1b/2a Study of GC1118 with 5-Fluorouracil, Leucovorin and Irinotecan (FOLFIRI) in Patients with Recurrent or Metastatic Colorectal Cancer. (PubMed, Cancer Res Treat)
    ORR was 42.5% (95% confidence interval [CI], 23.5-62.0), and median progression-free survival was 6.7 months (95% CI, 4.0-8.0). GC1118 administered weekly at 3 mg/kg in combination with FOLFIRI appears as an effective and safe treatment option in recurrent/metastatic CRC.
    P1/2 data • Journal • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    KRAS wild-type • BRAF wild-type • NRAS wild-type • EGFR positive
    |
    5-fluorouracil • irinotecan • leucovorin calcium • GC-1118A
    1year
    A multicenter, phase II trial of GC1118, a novel anti-EGFR antibody, for recurrent glioblastoma patients with EGFR amplification. (PubMed, Cancer Med)
    This study did not meet the primary endpoint (PFS6); however, we found that immune signatures were significantly upregulated in the tumors with regression upon GC1118 therapy, which signifies the potential of immune-mediated antitumor efficacy of GC1118.
    P2 data • Clinical Trial,Phase II • Journal
    |
    EGFR amplification
    |
    GC-1118A
    over1year
    GC1118 in Recurrent Glioblastoma Patients With High EGFR Amplification (clinicaltrials.gov)
    P2, N=13, Completed, Samsung Medical Center | Unknown status --> Completed | N=23 --> 13
    Trial completion • Enrollment change
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR amplification
    |
    GC-1118A
    almost2years
    EGFR-targeted Therapy for Gastric Cancer (clinicaltrials.gov)
    P2, N=19, Recruiting, National Cancer Center, Korea | N=38 --> 19 | Trial primary completion date: Dec 2022 --> Dec 2023
    Enrollment change • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR amplification
    |
    paclitaxel • GC-1118A
    over2years
    A Study to Assess Safety, Efficacy, Immunogenicity, PK of GC1118 With Combination Chemotherapy (clinicaltrials.gov)
    P1b/2a, N=53, Completed, Green Cross Corporation | Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Jan 2022
    Trial completion • Trial completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    EGFR expression • KRAS wild-type • BRAF wild-type • NRAS wild-type • BRAF wild-type + NRAS wild-type
    |
    5-fluorouracil • irinotecan • leucovorin calcium • GC-1118A
    over3years
    EGFR-targeted Therapy for Gastric Cancer (clinicaltrials.gov)
    P2, N=38, Recruiting, National Cancer Center, Korea | Not yet recruiting --> Recruiting | N=85 --> 38
    Clinical • Enrollment open • Enrollment change • Combination therapy
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR amplification
    |
    paclitaxel • GC-1118A
    almost4years
    A Target-Mediated Drug Disposition Population Pharmacokinetic Model of GC1118, a Novel Anti-EGFR Antibody, in Patients with Solid Tumors. (PubMed, Clin Transl Sci)
    Monte-Carlo simulation experiments of the PK profiles and EGFR receptor occupancies (RO) by GC1118 based on the final model showed that Q1W at 4 or 5 mg/kg will produce a better anti-tumor effect than Q2W at 8 mg/kg. Because GC1118 was safer at 4 mg/kg than 5 mg/kg in the phase I study, we suggest to test the 4 mg/kg Q1W regimen in further clinical trials with GC1118.
    Clinical • PK/PD data • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    GC-1118A
    over4years
    [VIRTUAL] Phase Ib/IIa study of GC1118 in combination with irinotecan or FOLFIRI in patients with metastatic solid tumors. (ASCO 2020)
    Phase 1b part was designed to evaluate weekly GC1118 (starting from 3 mg/kg) in combination with biweekly irinotecan (180mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 400mg/m2, 5-FU 400 mg/m2 bolus, and 5-FU 2400mg/m2 over 46hrs) in a 3+3 design... The MTD and RP2D of weekly GC1118 in combination with irinotecan or FOLFIRI was 3mg/kg. Preliminary results of GC1118 and FOLFIRI as a 2nd line treatment in mCRC suggests promising antitumor activity and acceptable safety profile. Research Funding: Green Cross Corporation
    Clinical • P1/2 data • Combination therapy
    |
    BRAF (B-raf proto-oncogene)
    |
    irinotecan • leucovorin calcium • GC-1118A • fluorouracil topical
    over4years
    GC1118, a novel anti-EGFR antibody, has potent KRAS mutation-independent antitumor activity compared with cetuximab in gastric cancer. (PubMed, Gastric Cancer)
    Taken together, GC1118 alone or in combination with cytotoxic chemotherapeutic agents exerted more potent anti-tumor effects than cetuximab in GC cells, regardless of KRAS status. These findings support the further clinical development of GC1118 for the treatment of GC.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    Erbitux (cetuximab) • cisplatin • Vectibix (panitumumab) • GC-1118A • fluorouracil topical