Evidence map›Paper›PMID 35397434›Full record

ArticleESMO open2022

Safety and preliminary activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody gatipotuzumab with the anti-EGFR tomuzotuximab in patients with refractory solid tumors.

S Ochsenreither, W M Fiedler, G D Conte, M Macchini, I Matos, B Habel, I Ahrens-Fath, F Raspagliesi, D Lorusso, U Keilholz and 7 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03360734 (A Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of Gatipotuzumab and Tomuzotuximab Combination in Patients With EGFR-Positive Metastatic Solid Tumors), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.8field-weighted citation impact, top 32% 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.

NCT03360734 phase1completednot on this map

A Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of Gatipotuzumab and Tomuzotuximab Combination in Patients With EGFR-Positive Metastatic Solid Tumors

TypeinterventionalSponsorGlycotope GmbHRan2017 to 2020Enrolled50ConditionsSolid Tumor, AdultArmsFirst part: Gatipotuzumab and Tomuzotuximab, Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Review
  3. Mucin-Targeted Antibodies for Ovarian Cancer.Seminars in nuclear medicine · 2025
    Review
  4. Review
  5. Review
  6. Article
  7. Article
  8. The multifaceted role of MUC1 in tumor therapy resistance.Clinical and experimental medicine · 2023
    Review
  9. Article
  10. Review
  11. Sensitivities and Dependencies ofMedicina (Kaunas, Lithuania) · 2022
    Article
  12. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 10 institutions in 3 countries.

S OchsenreitherCharité Comprehensive Cancer Center, Berlin, Germany; Charité, Department of Hematology, Oncology and Tumor Immunology, Berlin, Germany; German Cancer Consortium (DKTK), Berlin, Germany. Electronic address: sebastian.ochsenreither@charite.de.
W M FiedlerUniversity Medical Center Hamburg-Eppendorf, Hubertus-Wald University Cancer Center, Hamburg, Germany.
G D ConteFondazione IRCCS San Raffaele Hospital, Milan, Italy.
M MacchiniFondazione IRCCS San Raffaele Hospital, Milan, Italy.
I MatosVall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain.
B HabelGlycotope GmbH, Berlin, Germany.
I Ahrens-FathGlycotope GmbH, Berlin, Germany.
F RaspagliesiFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
D LorussoFondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
U KeilholzCharité Comprehensive Cancer Center, Berlin, Germany; German Cancer Consortium (DKTK), Berlin, Germany; Berlin Institute of Health at Charité - Universitätsmedizin Berlin, Berlin, Germany.
C RollingUniversity Medical Center Hamburg-Eppendorf, Hubertus-Wald University Cancer Center, Hamburg, Germany.
M KebenkoUniversity Medical Center Hamburg-Eppendorf, Hubertus-Wald University Cancer Center, Hamburg, Germany.
K F KlinghammerCharité Comprehensive Cancer Center, Berlin, Germany; Charité, Department of Hematology, Oncology and Tumor Immunology, Berlin, Germany.
O SaavedraVall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain.
H BaumeisterGlycotope GmbH, Berlin, Germany.
A ZurloGlycotope GmbH, Berlin, Germany.
E GarraldaVall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain.
Glycotope (Germany) · DEVall d'Hebron Hospital Universitari · ESFondazione IRCCS Istituto Nazionale dei Tumori · ITIstituto di Ricovero e Cura a Carattere Scientifico San RaffaeleCharité - Universitätsmedizin Berlin · DEDeutschen Konsortium für Translationale Krebsforschung · DEGerman Cancer Society · DEUniversität Hamburg · DEUniversity Cancer Center Hamburg · DEUniversity Medical Center Hamburg-Eppendorf · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase I GATTO study (NCT03360734) explored the feasibility, tolerability and preliminary activity of combining gatipotuzumab, a novel humanized monoclonal antibody binding to the tumor-associated epitope of mucin 1 (TA-MUC1) and an anti-epidermal growth factor receptor (anti-EGFR) antibody in refractory solid tumors. PATIENTS AND

methodsInitially the study enrolled primary phase (PP) patients with EGFR-positive metastatic solid tumors, for whom no standard treatment was available. Patients received gatipotuzumab administered at 1400 mg every 2 weeks, 6 weeks after the start of the glyco-optimized anti-EGFR antibody tomuzotuximab at 1200 mg every 2 weeks. As this regimen was proven safe, enrollment continued in an expansion phase (EP) of patients with refractory metastatic colorectal cancer, non-small-cell lung cancer, head and neck cancer and breast cancer. Tomuzotuximab and gatipotuzumab were given at the same doses and gatipotuzumab treatment started 1 week after the first dose of the anti-EGFR antibody. Additionally, investigators could use a commercial anti-EGFR antibody in place of tomuzotuximab.

resultsA total of 52 patients were enrolled, 20 in the PP and 32 in the EP. The combined treatment was well tolerated and no dose-limiting toxicity was observed in the whole study, nor related serious adverse event or death. Preliminary activity of the combination was observed, with one and four RECIST partial responses in the PP and EP, all in colorectal cancer patients. The trial was accompanied by a comprehensive translational research program for identification of biomarkers, including soluble TA-MUC1 (sTA-MUC1) in serum. In the EP, patients with baseline sTA-MUC1 levels above the median appeared to have improved progression-free survival and overall survival.

conclusionsCombination of a TA-MUC1-targeting antibody and an EGFR-targeting antibody is safe and feasible. Interesting antitumor activity was observed in heavily pretreated patients. Future studies should test this combination together with chemotherapy and explore the potential of sTA-MUC1 as a companion biomarker for further development of the combination.

Indexed as

Antineoplastic AgentsCarcinoma, Non-Small-Cell LungColorectal NeoplasmsLung NeoplasmsAntibodies, MonoclonalErbB ReceptorsHumansMucin-1Antibodies, MonoclonalAntineoplastic AgentsErbB ReceptorsMUC1 protein, humanMucin-1colorectal cancerEGFRlung cancermonoclonal antibodyphase ITA-MUC1

Identifiers

PMID35397434
PMCPMC9058922
OpenAlexW4223453843

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Registered trials

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.