NCT03360734: GATTO

Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors

Completed Phase 1 Last updated 12 July 2021

What this trial tests

Phase 1 trial testing First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab) in Solid Tumor, Adult in 50 participants. Completed in 29 September 2020.

Timeline

2 November 2017

Primary endpoint
4 May 2020

29 September 2020

Quick facts

Lead sponsor	Glycotope GmbH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	2 November 2017
Primary completion	4 May 2020
Estimated completion	29 September 2020
Sites	4 locations across Italy, Germany, Spain

Drugs / interventions tested

• First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)

Conditions studied

• Solid Tumor, Adult — all drugs for Solid Tumor, Adult →

Sponsor

Glycotope GmbH — full company profile →

Who can join

18 and older, any sex, with Solid Tumor, Adult. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This was a single arm phase Ib study to evaluate the safety and efficacy of combined Tomuzotuximab and Gatipotuzumab therapy in patients with metastatic solid tumors expressing EGFR for whom no standard treatment is available. Patients who had relapsed following their most recent line of chemotherapy and who met all other entry criteria at Screening were enrolled to receive Tomuzotuximab and Gatipotuzumab in combination.

During the extension phase, instead of Tomuzotuximab a commercially avalaible anti-EGFR antibody, i.e. Cetuximab (including any approved biosimilar), Panitumumab, or Necitumumab could be given to patients with cancers for which their use is approved.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
2. Glycosylation: mechanisms, biological functions and clinical implications.
   He M, Zhou X, Wang X. · · 2024 · cited 248× · PMID 39098853 · DOI 10.1038/s41392-024-01886-1
3. Targeting Tumor Glycans for Cancer Therapy: Successes, Limitations, and Perspectives.
   Berois N, Pittini A, Osinaga E. · · 2022 · cited 96× · PMID 35158915 · DOI 10.3390/cancers14030645
4. Preclinical evaluation of AFM24, a novel CD16A-specific innate immune cell engager targeting EGFR-positive tumors.
   Wingert S, Reusch U, Knackmuss S, Kluge M, et al · · 2021 · cited 55× · PMID 34325617 · DOI 10.1080/19420862.2021.1950264
5. The intriguing roles of Siglec family members in the tumor microenvironment.
   Jiang KY, Qi LL, Kang FB, Wang L. · · 2022 · cited 34× · PMID 35418152 · DOI 10.1186/s40364-022-00369-1
6. Anti-glycan monoclonal antibodies: Basic research and clinical applications.
   Gillmann KM, Temme JS, Marglous S, Brown CE, et al · · 2023 · cited 25× · PMID 36905763 · DOI 10.1016/j.cbpa.2023.102281
7. The (Sialyl) Tn antigen: Contributions to immunosuppression in gastrointestinal cancers.
   Rajesh C, Radhakrishnan P. · · 2022 · cited 23× · PMID 36686742 · DOI 10.3389/fonc.2022.1093496
8. Defucosylation of Tumor-Specific Humanized Anti-MUC1 Monoclonal Antibody Enhances NK Cell-Mediated Anti-Tumor Cell Cytotoxicity.
   Gong Y, Klein Wolterink RGJ, Gulaia V, Cloosen S, et al · · 2021 · cited 14× · PMID 34070311 · DOI 10.3390/cancers13112579