Date: 2013-12-00
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Genmab (Denmark)
Product: HuMax®-TF-ADC
Action
mechanism: HuMax-TF-ADC is an antibody-drug conjugate (ADC) composed of a human antibody against tissue factor (TF) conjugated to the cytotoxic drug monomethyl auristatin E (MMAE). HuMax-TF-ADC is being developed for the treatment of solid cancers. TF is an attractive tumor target because of its high expression in a broad range of solid cancers. After binding to TF, HuMax-TF-ADC enters the tumor cells where the cytotoxic agent is specifically released, leading to cell death. HuMax-TF-ADC was demonstrated to have potent anti-tumor activity in in vivo studies in mouse models in which a diverse panel of patient-derived tumors was assessed. HuMax-TF-ADC was shown to have an acceptable safety profile in non-clinical safety studies.
Genmab is developing HuMax-TF-ADC using Seattle Genetics' ADC technology under an agreement between the companies. Seattle Genetics may elect to co-develop HuMax-TF-ADC with Genmab at the end of Phase I clinical development.
Disease: solid tumors ( ovarian cancer, cervix cancer endometrium cancer, bladder cancer, prostate cancer, esophagus cancer, lung cancer)
Therapeutic area: Cancer - Oncology
Country: Denmark, USA, UK
Trial
details: The purpose of the trial is to establish the tolerability of HuMax-TF-ADC in a mixed population of patients with specified solid tumors. (NCT02001623)
Latest
news: This Phase I dose escalation trial of HuMax-TF-ADC to treat multiple solid tumors was initiated in December 2013.
* On July 18, 2013, Genmab has announced the filing of an Investigational New Drug (IND) application with the FDA to start a Phase I dose escalation trial of HuMax-TF-ADC to treat multiple solid tumors. A maximum of 78 patients with cancer of the ovary, cervix, endometrium, bladder, prostate, head & neck, esophagus or lung that have failed or are not eligible for standard treatments will be enrolled in the study. The safety and tolerability of HuMax-TF-ADC will be established during a dose escalation part of the study. This will be followed by a cohort expansion part that will investigate longer-term safety and potential signs of anti-tumor activity.
