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