Date: 2017-03-23
Type of
information: Completion of the trial
phase: 1
Announcement: completion of the trial
Company: Alligator Bioscience (Sweden)
Product: ADC-1013
Action
mechanism:
- monoclonal antibody. ADC-1013 is an agonistic fully human monoclonal antibody targeting CD40, an immunostimulatory receptor found on antigen-presenting cells such as dendritic cells. ADC-1013 has been developed in close collaboration with Professor Thomas Tötterman, Uppsala University, Sweden. Professor Tötterman is a pioneer in directed immunotherapy of cancer, a concept where the immune system is selectively activated locally in the tumor microenvironment in order to reduce systemic side effects while optimizing systemic anti-tumor effects. Professor Tötterman´s group has performed a number of successful in-vivo experiments demonstrating the powerful immune mediated anti-tumor effects of ADC-1013. The pre-clinical assessment of ADC-1013 indicates a favorable tolerability profile, which is likely to be further improved by the intratumoral route of administration in the first clinical trial. Manufacturing of ADC-1013 was performed by Cobra Biologics, using the maxXpress platform and the Ubiquitous Chromatin Opening Element (UCOE) technology, and by BioInvent International, who performed process development and manufacturing of the non-GMP and GMP batches.
Disease: advanced solid tumors
Therapeutic
area: Cancer - Oncology
Country: Denmark, Sweden, UK
Trial
details:
- The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered as repeated injections directly into the tumor tissue in patients with advanced solid tumors. The study will enroll up to 40 patients during the dose escalation and expansion phases at five centers in the United Kingdom, Denmark and Sweden. (NCT02379741)
Latest
news:
- • On March 23, 2017, Alligator Bioscience announced that the first phase I study with ADC-1013, a human, monospecific, agonistic IgG1 antibody for cancer immunotherapy, has been completed. The phase I trial, which began in April 2015, is a dose-escalation study involving intratumoral and intravenous administration of ADC-1013 at five clinical sites in Sweden, Denmark and the UK. The study includes 24 patients and ten different tumor types. The data will now be analyzed, focusing on safety and tolerability, pharmacokinetics, immunogenicity, biomarker response and clinical response evaluation. The aim is to present the results during the fourth quarter of 2017 at a scientific meeting, followed by a publication in a scientific journal.
- • On April 27, 2015, Alligator Bioscience announced that the first patient was dosed in the recently initiated phase 1 clinical trial of the immuno-oncology antibody ADC-1013. The clinical phase 1 trial is a first-in-human trial for patients with advanced solid tumor disease.
- • On April 7, 2015, Alligator Bioscience, a privately held Swedish biotech company developing immuno-oncology antibodies for directed immunotherapy of cancer, announced initiation of a phase 1 clinical trial of ADC-1013 for patients with advanced solid tumor disease. The phase 1 trial is a first-in-human, multicenter, open-label, multiple ascending dose study in patients with advanced solid tumors to determine the safety, pharmacokinetics and pharmacodynamics of intratumorally administered ADC-1013. The study includes a dose escalation part followed by an expansion at the optimal biological dose level. The primary endpoints are to identify the maximum tolerated dose and to study the safety and tolerability of ADC-1013. In addition, the trial will evaluate pharmacokinetics, immunogenicity, pharmacodynamics, antitumor activity, as well as mechanism of action of ADC-1013. The study will enroll up to 40 patients during the dose escalation and expansion phases at five centers in the United Kingdom, Denmark and Sweden. The study is managed by the international oncology contract research organization Theradex.
Is
general: Yes
