Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
9 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Oxford BioTherapeutics Ltd
You may qualify if…
- ✓ 1. Subject is ≥ 18 years of age (at the time of signing the ICF) with non-curative recurrent and/or metastatic solid tumors for which a standard therapy is not available or is no longer effective.
- ✓ 2. Subject has histologically and/or cytologically confirmed solid tumors.
- ✓ 3. Subject with Breast cancer:
- ✓ 1. Subject with hormone-receptor positive (as per local laboratory) recurrent locally advanced or metastatic breast cancer, regardless of HER2 status, must have received at least two prior lines of endocrine therapy in the adjuvant or metastatic setting, either as monotherapy or in combination with targeted therapy
- ✓ 2. Subject with recurrent locally advanced or metastatic non-curative HER2 negative breast cancer (based on most recently analyzed biopsy), HER2 status is defined as per ASCO-CAP guidelines as negative, if in situ hybridization test or IHC status is 0, 1+, or 2+.
- ✓ 3. Subject with triple negative breast cancer are eligible after at least one prior line of cytotoxic chemotherapy in the metastatic setting.
- ✓ 4. Subject with prior adjuvant or neoadjuvant chemotherapy allowed.
- ✓ 4. Subject has received a maximum of two prior lines of cytotoxic chemotherapy in the metastatic setting. Subject who received three up to five prior lines of cytotoxic chemotherapy in the metastatic setting are eligible, if the last administration of cytotoxic chemotherapy was at least 12 weeks prior to Cycle 1 Day 1
You may not qualify if…
- ✕ 1. Subject has received any chemotherapy within 28 days prior to Cycle 1 Day 1.
- ✕ 2. Subject has received any other systemic anticancer therapy within 28 days or 5 half-lives of Cycle 1 Day 1.
- ✕ 3. Subject has symptomatic visceral crisis requiring chemotherapy per Investigator judgment for non TNBC.
- ✕ 4. Subject with colorectal cancer and pancreatic cancer are not eligible for the study.
- ✕ 5. Subject with peritoneal involvement, i.e., peritoneal carcinomatosis, are not eligible for the study.
- ✕ 6. Subject has not recovered from the acute toxic effects (CTCAE grade ≤ 1) of prior anticancer therapy, radiation, or major surgery/significant trauma (except alopecia or other toxicities not considered a safety risk for the subject at the Investigator's discretion).
- ✕ 7. Subject has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
- ✕ 8. Subject has had radiotherapy ≤ 4 weeks prior to starting study drug.
Where it's recruiting
Phoenix
Los Angeles · Santa Monica
Tampa
Iowa City
Edgewood
Jackson
Santa Fe
New York
Pittsburgh
Source: ClinicalTrials.gov · NCT04064359 · last updated 2025-09-16