A phase I trial of the trifunctional anti Her2 × anti CD3 antibody ertumaxomab in patients with advanced solid tumors

57Citations
Citations of this article
92Readers
Mendeley users who have this article in their library.

This article is free to access.

Abstract

Background: Ertumaxomab (ertu) is a bispecific, trifunctional antibody targeting Her2/neu, CD3 and the Fcγ-receptors I, IIa, and III forming a tri-cell complex between tumor cell, T cell and accessory cells. Methods: Patients (pts) with Her2/neu (1+/SISH positive, 2+ and 3+) expressing tumors progressing after standard therapy were treated to investigate safety, tolerability and preliminary efficacy. In this study, ertu was applied i.v. in 2 cycles following a predefined dose escalating scheme. Each cycle consisted of five ascending doses (10-500 μg) applied weekly within 28 days with a 21 day treatment-free interval. If 2 pts experienced a dose limiting toxicity (DLT) at a given dose level, the maximum tolerated dose (MTD) had been exceeded. Results: Fourteen heavily pretreated pts (e.g. breast, rectal, gastric cancer) were enrolled in the four main cohorts. Three (21 %) pts had to be replaced. Two serious adverse events (SAE) with possible relation to the investigational drug were seen, both fully reversible. A DLT was not detected. Consequently, the MTD could not be determined. All adverse events (AE) were transient and completely reversible. Most frequent AEs were fatigue (14/14), pain (13/14), cephalgia (12/14), chills (11/14), nausea (8/14), fever (7/14), emesis (7/14) and diarrhea (5/14). Single doses up to 300 μg were well tolerated (total dose up to 800 μg per cycle). We observed one partial remission and two disease stabilizations after first treatment cycle. Conclusions: Single doses up to 300 μg could be safely administered in an escalating dose scheme. Immunological responses and clinical activity warrant further evaluation in patients with Her2 over expressing tumors. Trial registration: EudraCT number: 2011-003201-14; ClinicalTrials.gov identifier: NCT01569412

Cited by Powered by Scopus

This article is free to access.

This article is free to access.

122Citations
168Readers

This article is free to access.

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Cite

CITATION STYLE

APA

Haense, N., Atmaca, A., Pauligk, C., Steinmetz, K., Marmé, F., Haag, G. M., … Al-Batran, S. E. (2016). A phase I trial of the trifunctional anti Her2 × anti CD3 antibody ertumaxomab in patients with advanced solid tumors. BMC Cancer, 16(1). https://doi.org/10.1186/s12885-016-2449-0

Readers over time

‘16‘17‘18‘19‘20‘21‘22‘23‘2408162432

Readers' Seniority

Tooltip

PhD / Post grad / Masters / Doc 27

57%

Researcher 15

32%

Professor / Associate Prof. 4

9%

Lecturer / Post doc 1

2%

Readers' Discipline

Tooltip

Medicine and Dentistry 20

43%

Biochemistry, Genetics and Molecular Bi... 14

30%

Agricultural and Biological Sciences 8

17%

Immunology and Microbiology 5

11%

Article Metrics

Tooltip
Mentions
News Mentions: 1

Save time finding and organizing research with Mendeley

Sign up for free
0