Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors and HER2-neg Breast Cancer
Status:
Recruiting
Trial end date:
2021-12-15
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate OBT076, which is a drug that combines an antibody
with an anti-cancer drug. This class of drugs are called Antibody-Drug Conjugates (ADC).
Antibodies are normally produced in the human body by the immune system to fight infections
but can be designed to target cancer cells and deliver an anti-cancer drug. OBT076 is
composed of an antibody that targets the CD205 protein on cancer cells and delivers an
anti-cancer drug which can kill them. OBT076 is an "Investigational Drug", which means that
it is still being studied and has not yet been approved by the US Food and Drug
Administration (FDA), the European Medicines Agency (EMA) or any other regulatory authorities
to be prescribed by doctors for the treatment of metastatic or recurrent solid tumors. The
use of OBT076 in this study is investigational.
This is a Phase I research study designed to look at several dose levels of the study drug to
find the highest dose level that is safe and well-tolerated (does not cause unacceptable side
effects), and to examine the effects of the study drug in a small group of research
participants. The study will also look at the effectiveness of OBT076 as an anti-cancer
therapy. Once the optimal dose is determined and safety is assessed, additional research
participants will be treated at the optimal dose level to further evaluate safety and
effectiveness.