OBT076 for Advanced Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any chemotherapy or other systemic anticancer therapy at least 28 days before starting the study drug. The protocol does not specify about other medications, so it's best to discuss your current medications with the study team.
What is the purpose of this trial?
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.
Research Team
Rutika Mehta
Principal Investigator
Moffitt Cancer Center
Gary Schwartz, MD
Principal Investigator
Columbia University
Lee Rosen, MD
Principal Investigator
University of California, Los Angeles
Monica Mita, MD
Principal Investigator
Cedars-Sinai
Olivier Rixe, MD
Principal Investigator
Quantum Santa Fe
Eligibility Criteria
Adults with non-curable recurrent/metastatic solid tumors positive for CD205, who've exhausted standard treatments or find them ineffective. Participants must have good organ and bone marrow function, an ECOG performance status of 0-1, measurable disease by radiology, and a maximum of two prior chemotherapy lines in the metastatic setting (up to five if last was over 12 weeks ago). Men must agree to contraception during the study and four months after; women of childbearing potential need a negative pregnancy test and use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OBT076 in 21-day cycles, with dose escalation and expansion phases
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- OBT076
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oxford BioTherapeutics Ltd
Lead Sponsor