Date: 2016-10-12
Type of
information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Janssen Research & Development, a J&J company (USA - NJ) Alligator Bioscience (Sweden)
Product: ADC-1013/JNJ-64457107
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 stage solid tumors
Therapeutic
area: Cancer - Oncology
Country: Australia, Belgium, Denmark, Israel, Spain, Sweden, USA
Trial
details:
- The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of JNJ-64457107 when administered intravenously (IV) to participants with advanced stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when administered IV to participants with non-small cell lung cancer (NSCLC), pancreatic cancer and cutaneous melanoma in Part 2. (NCT02829099)
Latest
news:
- • On October 12, 2016, Alligator Bioscience announced that dosing has started in a second clinical phase I study with the CD40 agonistic immuno-oncology antibody ADC-1013. A first trial has been initiated in April 2015. The study was later expanded to include both intratumoral and intravenous dose escalation. An additional clinical phase I study started dosing on 9 October 2016. The second study is sponsored by Janssen Research & Development, and includes dose escalation with ADC-1013 (JNJ-64457107) administered intravenously. The Alligator sponsored trial continues to enroll patients for intratumoral dose escalation, while further enrollment for intravenous dose escalation will take part in the Janssen study.
Is
general: Yes
