Combination of Gatipotuzumab and Tomuzotuximab in Patients With Solid Tumors

Sponsor
Glycotope GmbH
Study ID
NCT03360734
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 2, 2017
Status verified
Jul 2021
Primary completion
May 4, 2020
Completion
Sep 29, 2020

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination
    First part: Combination of Gatipotuzumab (GAT) and Tomuzotuximab (TOM) Treatment: 5 weeks monotherapy with TOM (Day 1: 60mg, Day 2: 660mg, Week 2: 1200mg, Week 4: 1200mg). Then combination of 1200mg TOM with 1400mg of GAT every two weeks until disease progression, as long as patient does not meet any other discontinuation criterion such as unacceptable toxicity. Second part: Combination of GAT and TOM or an approved anti-EGFR antibody, i.e. Cetuximab, Panitumumab, or Necitumumab Treatment: One week monotherapy with TOM (Week 1, Day 1: 60mg, Day 2: 660mg). Then 1200mg TOM in combination with 1400mg of GAT every two weeks until disease progression, as long as patient does not meet any other discontinuation criterion such as unacceptable toxicity or commercial anti-EGFR antibody (dosage according to local practices) in combination with 1400mg of GAT every two weeks until disease progression or until unacceptable toxicity

Primary Outcome Measure

Safety: Incidence and Severity of adverse events (AEs) and IRRs [ Time Frame: 12 months ]

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