Evidence map›Paper›PMID 37260332›Full record

ArticleThe oncologist2023

A Phase I Trial of the Dual MET Kinase/OCT-2 Inhibitor OMO-1 in Metastatic Solid Malignancies Including MET Exon 14 Mutated Lung Cancer.

Melinda A Pruis, Matthew G Krebs, Ruth Plummer, Filip De Vos, Eric Angevin, Hans Prenen, Martin D Forster, Glen Clack, Annegret Van der Aa, Marc Tjwa and 3 more

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

Article in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.5field-weighted citation impact, top 30% 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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
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

13 authors at 7 institutions in 4 countries.

Melinda A PruisDepartment of Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.ORCID 0000-0003-4361-0020
Matthew G KrebsDivision of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester and The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.ORCID 0000-0001-7540-3064
Ruth PlummerOncology Department, Newcastle University and Newcastle Hospitals NHS Foundation Trust, Newcastle, UK.ORCID 0000-0003-0107-1444
Filip De VosDepartment Medical Oncology, University Medical Center Utrecht, University Utrecht, Utrecht, The Netherlands.ORCID 0000-0002-9082-5991
Eric AngevinDrug Development Department (DITEP), Gustave Roussy Institute, Villejuif, France.ORCID 0000-0001-6249-7209
Hans PrenenDepartment of Medical Oncology, University Hospital Antwerp, Antwerp, Belgium.ORCID 0000-0001-8802-7352
Martin D ForsterDepartment of Oncology, UCL Cancer Institute/ University College London Hospitals NHS Foundation Trust, London, UK.ORCID 0000-0002-8565-0541
Glen ClackOctimet Oncology NV, Belgium.ORCID 0000-0002-7782-9891
Annegret Van der AaOctimet Oncology NV, Belgium.ORCID 0000-0001-9095-8164
Marc TjwaOctimet Oncology NV, Belgium.
Ellen JansenOctimet Oncology NV, Belgium.
Timothy PereraDepartment of Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.
Martijn P LolkemaDepartment of Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.ORCID 0000-0003-0466-2928
Erasmus MC Cancer Institute · NLAntwerp University Hospital · BEInstitut Gustave Roussy · FRManchester Academic Health Science Centre · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBUniversity College London Hospitals NHS Foundation Trust · GBUtrecht University · NL

Funding

OCTIMET
6 · The paper itself

Abstract

introductionTargeted therapy in non-small cell lung cancer (NSCLC) patients with mesenchymal epithelial transition (MET) exon 14 skipping mutations (METex14) and MET amplifications has improved patients' outcomes. The development of more potent MET kinase inhibitors could further benefit these patients. The aim of this trial is to determine the safety and recommended phase 2 dose (RP2D) of OMO-1 (an oral dual MET kinase/OCT-2 inhibitor) and to assess preliminary clinical efficacy in METex14-positive NSCLC and other MET-positive solid tumors. MATERIALS AND

methodsThis was a first-in-patient, open-label, multicenter study of OMO-1 in patients with locally advanced or metastatic solid malignancies. A standard 3 + 3 dose escalation design was utilized starting at a dose level of 100 mg BID continuously. Preliminary efficacy was investigated in patients with METex14-positive NSCLC, and MET amplified NSCLC and other solid tumors (MET basket).

resultsIn the dose-escalation part, 24 patients were included in 5 dose levels ranging from 100 mg twice daily (BID) to 400 mg BID. Most common adverse events (≥ 20%) were nausea, fatigue, vomiting, increased blood creatinine, and headache. The RP2D was determined at 250 mg BID. In the expansion cohorts, 15 patients were included (10 in METex14-positive NSCLC cohort and 5 in MET basket cohort) and received either 200 or 250 mg BID. Eight out of the 10 patients with METex14 positive NSCLC had stable disease as the best response.

conclusionOMO-1 was tolerated at the dose of 250 mg BID and shows initial signs of MET inhibition and anti-tumor activity in METex14 mutated NSCLC patients.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsNeoplasms, Second PrimaryExonsHumansMutationProtein Kinase InhibitorsProto-Oncogene Proteins c-metProtein Kinase InhibitorsProto-Oncogene Proteins c-metcancerexon 14METNSCLCOMO-1

Identifiers

PMID37260332
PMCPMC10712729
OpenAlexW4378952407

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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.