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Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors

NCT03360734 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-07-12

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult

Interventions

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

Sponsors & Collaborators

  • Glycotope GmbH

    lead INDUSTRY

Principal Investigators

  • Sebastian Ochsenreither, Dr. med. · Charité Benjamin Franklin Comprehensive Cancer Center,Hindenburgdamm 30,12200/12203 Berlin, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2020-05-04
Completion
2020-09-29

Countries

  • Germany
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03360734 on ClinicalTrials.gov