Actively Recruiting
Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors
Led by Oxford BioTherapeutics Ltd · Updated on 2025-09-16
200
Participants Needed
27
Research Sites
440 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older with non-curative recurrent or metastatic solid tumors lacking effective standard therapy
- Histologically or cytologically confirmed solid tumors
- For breast cancer patients: hormone-receptor positive with at least two prior endocrine therapies, HER2-negative status, or triple negative with prior chemotherapy
- Maximum of two prior lines of cytotoxic chemotherapy in metastatic setting; up to five prior lines allowed if last chemotherapy was at least 12 weeks before study start
- Tumor positive for CD205 antigen by immunohistochemistry
- ECOG performance status of 0-1
- Measurable disease by RECIST Version 1.1
- Adequate organ and bone marrow function
- Ability to understand and consent to study procedures
- Willingness to comply with study visit schedule
- Female participants of childbearing potential must have negative pregnancy test before treatment, use effective birth control during and for 4 months after treatment, and agree to avoid egg donation and pregnancy during this time
- Sexually active males must agree to use condoms, avoid sperm donation, and not father a child during the study and for 4 months after last dose
You will not qualify if you...
- Chemotherapy or other systemic anticancer therapy within 28 days before study start
- Symptomatic visceral crisis requiring chemotherapy (non-triple negative breast cancer)
- Diagnosis of colorectal or pancreatic cancer
- Presence of peritoneal carcinomatosis
- Incomplete recovery from prior anticancer therapy, radiation, surgery, or trauma
- Major surgery within 14 days before treatment
- Radiotherapy within 4 weeks before treatment
- History or presence of symptomatic brain metastases
- Other malignancies within 5 years prior to screening
- Known allergy or contraindication to OBT076 components
- Significant medical, laboratory, or psychiatric conditions that contraindicate study participation
- SARS-CoV-2 vaccination within 7 days before treatment
- Conditions affecting data interpretation
- Lactating or breastfeeding
- History or ongoing interstitial lung disease, drug-induced pneumonitis, or severe COPD
- Active or chronic corneal disorder or Sjogren's syndrome
- Uncontrolled skin disorders
- Significant cardiac disease within previous 6 months
- HIV infection unless on stable antiviral therapy with undetectable viral load
- Female of childbearing potential who do not meet birth control requirements
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
- History of allogeneic organ transplant
- Grade 3 or 4 immune-related adverse events from prior checkpoint inhibitors
- Active or recent autoimmune disease requiring systemic treatment
- Additional exclusions for Part E related to gemcitabine contraindications, corticosteroid or immunosuppressive use, CNS metastasis, recent infections or hospitalizations, blood count thresholds, prior treatments, and refractory disease status
AI-Screening
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Trial Site Locations
Total: 27 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85084
Completed
2
Cedars-Sinai
Los Angeles, California, United States, 90048
Completed
3
UCLA
Santa Monica, California, United States, 90404
Completed
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Completed
5
The State University of Iowa
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
6
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Completed
7
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Completed
8
Quantum Santa Fe
Santa Fe, New Mexico, United States, 87505
Completed
9
Columbia University Medical Center
New York, New York, United States, 10032
Completed
10
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Completed
11
Institut Jules Bordet
Brussels, Belgium
Actively Recruiting
12
AZ Groeninge
Kortrijk, Belgium
Completed
13
Institut Paoli Calmettes
Marseille, France
Actively Recruiting
14
GHP Saint-Joseph
Paris, France
Actively Recruiting
15
Hopital Saint Antoine
Paris, France
Completed
16
Hopital Saint Louis
Paris, France
Actively Recruiting
17
Centre Eugène Marquis
Rennes, France
Actively Recruiting
18
ICANS - Institut de cancérologie Strasbourg
Strasbourg, France
Actively Recruiting
19
Institut Gustave Roussy - IGR
Villejuif, France
Actively Recruiting
20
University General Hospital Attikon
Chaïdári, Athens, Greece, 12462
Actively Recruiting
21
Metropolitan Hospital
Athens, Greece
Completed
22
Sotiria General Hospital
Athens, Greece
Actively Recruiting
23
University General Hospital of Heraklion
Heraklion, Greece
Actively Recruiting
24
EuroMedica
Thessaloniki, Greece, GR-54645
Completed
25
START Barcelona HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
26
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
27
University Hospital Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
Research Team
M
Medical Monitor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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