NCT03360734

Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Glycotope GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Tomuzotuximab (CetuGEX®) is an improved second-generation anti-epidermal growth factor receptor (EGFR) antibody that specifically binds to EGFR and acts as a competitive antagonist at the EGFR ligand binding site. Gatipotuzumab (PankoMab-GEX®) is a novel glyco-engineered humanized monoclonal antibody, which recognizes the tumor-specific epitope of mucin-1 (TA-MUC1). Gatipotuzumab targets and binds TA-MUC1 epitopes on the surface of tumor cells, potentially activating the immune system to induce ADCC against TA-MUC1 expressing tumor cells. Based on compelling preclinical evidence suggesting a complex interaction between EGFR and TA-MUC1 expressed on the tumor cell surface in driving carcinogenesis, this study assessed the tolerability, safety and preliminary activity of targeting EGFR and TA-MUC1 with glycoengineered antibodies. After the safe treatment of 20 patients and the absence of dose-limiting toxicity (DLT), the combination of the two antibodies was considered safe and was started in the second week of treatment for the additional 30 patients to be enrolled in the extension cohort.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)	Two monoclonal antibodies, Gatipotuzumab is anti-TAMUC1, Tomuzotuximab is anti-EGFR

Timeline

• Start date: 2017-11-02
• Primary completion: 2020-05-04
• Completion: 2020-09-29
• First posted: 2017-12-04
• Last updated: 2021-07-12

Locations

4 sites across 3 countries: Germany, Italy, Spain