Evidence map›Paper›PMID 31164456›Full record

ArticleThe oncologist2019

A First-in-Human Phase I Study of GC1118, a Novel Anti-Epidermal Growth Factor Receptor Antibody, in Patients with Advanced Solid Tumors.

Do-Youn Oh, Keun-Wook Lee, Sae-Won Han, Jin Won Kim, Jung-Won Shin, Seong-Jin Jo, Jonghwa Won, Seokyung Hahn, Howard Lee, Woo Ho Kim and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.4field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Analysis of EGFR binding hotspots for design of new EGFR inhibitory biologics.Protein science : a publication of the Protein Society · 2024
    Review
  4. Article
  5. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Do-Youn OhDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Sae-Won HanDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Jin Won KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Jung-Won ShinDepartment of Dermatology, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Seong-Jin JoDepartment of Dermatology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Jonghwa WonGC Pharma, Yongin, Korea.
Seokyung HahnDivision of Medical Statistics, Medical Research Collaborating Center, Seoul National University Hospital, Seoul, Korea.
Howard LeeDepartment of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Woo Ho KimDepartment of Pathology, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea.
Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, Seoul, Korea bangyj@snu.ac.kr.
Seoul National University Hospital · KRSeoul National University Bundang Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedGC1118 is a novel fully human anti-epidermal growth factor receptor (EGFR) antibody with unique binding epitopes and different ligand-binding inhibitory activity compared with cetuximab or panitumumab.GC1118 showed promising antitumor activity, especially in patients with colorectal cancer resistant to prior EGFR antibody. Skin toxicities were more common and diarrhea was less frequent compared with other anti-EGFR antibodies.

backgroundGC1118 is a novel monoclonal antibody targeting epidermal growth factor receptor (EGFR) with more potent ligand inhibition than cetuximab or panitumumab. We conducted a first-in-human, phase I study of GC118 in patients with refractory solid tumors.

methodsIn the dose escalation part, GC1118 was administered on days 1, 8, 15, and 22, followed by a 2-week rest, during which dose-limiting toxicities (DLTs) were evaluated. In the expansion part, patients were enrolled into three cohorts (Cohort 1 [C1], patients with colorectal cancer [CRC] without prior anti-EGFR treatment; Cohort 2 [C2], patients with CRC with tumors resistant to anti-EGFR therapy; Cohort 3 [C3], EGFR-overexpressing gastric cancer).

resultsIn the dose escalation part, 24 patients were treated at five dose levels: 0.3, 1.0, 3.0, 4.0, and 5.0 mg/kg. In the 5.0 mg/kg cohort, two patients experienced DLTs (skin toxicities). The maximum-tolerated dose (MTD) was 4.0 mg/kg. Common adverse events were skin toxicities. In the expansion part, 39 patients were enrolled. In Cohort 1, stable disease (SD) was observed in 58%; in Cohort 2, partial response (PR) 17% and SD 8%; in Cohort 3, PR 8% and SD 17%.

conclusionGC1118 showed promising antitumor activity and was well tolerated. Infrequent diarrhea compared with other anti-EGFR antibodies might be advantageous for further development.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsColorectal NeoplasmsDose-Response Relationship, DrugDrug Administration ScheduleDrug EruptionsErbB ReceptorsFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm StagingProgression-Free SurvivalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsEGFR protein, humanErbB ReceptorsGC1118

Identifiers

PMID31164456
PMCPMC6693725
OpenAlexW2948206428

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.