First in Human, Dose-Escalating Study of HuMaX®-TF-ADC in solid Tumour
Research type
Research Study
Full title
First-in-human, dose-escalating safety study of tissue factor specific antibody drug conjugate (HuMax® TF ADC) in patients with locally advanced and/or metastatic solid tumors known to express tissue factor
IRAS ID
135103
Contact name
Johann de Bono
Sponsor organisation
Genmab A/S
Eudract number
2013-001074-15
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The present study is a Phase I, multicentre, open label, First-in-Human, dose-escalating safety study of HuMax®-TF-ADC in patients with locally advanced or metastatic solid tumours known to express tissue factor.
The purpose of this research study is to establish the safety profile of the medication in patients with different solid tumours that express a special protein on the surface called tissue factor..
The study drug, HuMax®-TF-ADC combines an antibody with a chemotherapeutic agent to selectively target the tumour cells and shows anti-tumour activity in previous animal studies. The patient population in the Dose
Escalation part will be patients with advanced cancers who have failed available standard treatments or who are not
candidates for standard therapy.The study consists of two parts: A Dose Escalation part in which a maximum of 48 patients will be included and a Cohort Expansion part where 30 patients will be enrolled based on the data obtained from the Dose Escalation part. The aim of the Cohort Expansion part is to provide further safety, tolerability
pharmacokinetic and anti-tumour activity data.The study will be conducted in maximally 5 sites in Denmark, the United Kingdom and the United States with up to 10 additional sites to be included in the same countries for the Cohort Expansion part.
Patients may be expected to participate in the study for up to 72 weeks
REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/1265
Date of REC Opinion
8 Oct 2013
REC opinion
Favourable Opinion