OBT076 for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new drug called OBT076 for people with advanced cancer. OBT076 is an antibody-drug conjugate, combining an antibody that targets cancer cells with a drug that can kill them. The trial aims to determine the highest safe dose of OBT076 and assess its effectiveness against cancer. Ideal candidates for this trial have difficult-to-treat cancers, particularly if their tumors test positive for the CD205 protein. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
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.
Is there any evidence suggesting that OBT076 is likely to be safe for humans?
Research has shown that OBT076 has a good safety record. In earlier studies, patients tolerated doses up to 3.0 mg/kg well. The main side effect was a manageable drop in white blood cells, which can increase the risk of infection. This indicates that while some side effects may occur, they are usually manageable and not severe.
OBT076 remains in the early testing stages, so researchers are closely studying its safety to determine the best dose that people can tolerate without serious side effects. Although the drug is not yet approved, these early results are promising for those considering joining a trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for advanced cancers, such as chemotherapy and targeted therapies, OBT076 is unique because it employs a novel approach by targeting CD205, a specific protein often found on the surface of cancer cells. This targeted mechanism allows OBT076 to potentially deliver more precise attacks on cancer cells while sparing healthy ones, which could mean fewer side effects compared to traditional options. Additionally, in combination arms, OBT076 is being used alongside balstilimab and gemcitabine, which may enhance its effectiveness against tough-to-treat cancers like metastatic non-small cell lung cancer and urothelial cancer. Researchers are excited about OBT076 because it offers a new way to tackle cancers that have become resistant to existing treatments.
What evidence suggests that OBT076 might be an effective treatment for advanced cancer?
Studies have shown that OBT076 works by attaching to a protein called CD205, often found in higher amounts on certain cancer cells, such as those in pancreatic, bladder, and triple-negative breast cancer. This mechanism helps the drug deliver a strong anti-cancer treatment directly to the cancer cells. Participants in this trial will receive OBT076 in various treatment arms, including dose escalation and expansion phases, to evaluate its safety and effectiveness. Early research indicates that OBT076 has a manageable safety profile, meaning its side effects are not severe and can be controlled. Initial results show promising signs of effectiveness, with the drug actively fighting cancer cells. These early findings suggest that OBT076 could be a potential treatment for cancers with high levels of CD205, but more research is needed to confirm its benefits.12367
Who Is on the 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
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- OBT076
Find a Clinic Near You
Who Is Running the Clinical Trial?
Oxford BioTherapeutics Ltd
Lead Sponsor