HuMax®-TF-ADC Dose Escalation Safety Study
Research type
Research Study
Full title
Dose-escalating safety trial of tissue factor specific antibody drug conjugate (HUMAX®-TF-ADC) in patients with locally advanced and/or metastatic solid tumours known to express tissue factor
IRAS ID
179637
Contact name
Johann de Bono
Contact email
Sponsor organisation
Genmab A/S
Eudract number
2015-001120-29
Clinicaltrials.gov Identifier
IND number, 115906
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
The purpose of this dose-escalation study is to establish the safety profile of a new study medication called HuMax®-TF-ADC. ‘Dose-escalation’ is where groups of 3 participants are entered at the lowest dose level and if no intolerable side effects occur the next group will be escalated to receive the next dose level. The study is ‘open-label’ so both the study doctor and participant will know which dose they are receiving.
This study will enroll patients who have different cancer types (either of the ovaries, cervix, endometrium, bladder, prostate, oesophagus or Non-Small Cell Lung Cancer (NSCLC)) which has come back, got worse or spread to other parts of the body. Their cancer will have not responded to available standard treatments or they may be unable to have standard therapy.
The tumours treated in this study are known to express a special protein on the surface of their tumour cells. This protein is called tissue factor. The study medication combines an antibody (a protein that selectively identifies and neutralises foreign substances) with a chemotherapeutic agent (a medication that kills tumour cells). Thereby the tumour cells can be selectively targeted, in that the antibody binds to the tissue factor on the tumour cells, delivers the chemotherapeutic agent and kills the tumour cells.
Approximately 24 participants will take part in this study at up to 5 research sites across the UK, Denmark and the US.
Participants will receive doses of the study medication in 28 day cycles for 4 cycles of treatment or until unacceptable side effects. Further cycles of treatment may occur depending on how the participant responds to treatment. Expected study participation time is 79 weeks.
Procedures in this study will include physical exams, blood sampling, electrocardiograms, CT Scans, Bone Scans (if applicable), Bleeding Assessments, Skin Toxicity Assessments and Neuropathy Assessments.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/1284
Date of REC Opinion
13 Oct 2015
REC opinion
Further Information Favourable Opinion