Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Oxford BioTherapeutics Ltd
Study ID
NCT04064359
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OBT076, a CD205-directed antibody-drug conjugate — DRUG
    Intravenous (IV) infusion of OBT076 every 3 weeks.

Study Details

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.

Key Dates

Start date
Jul 25, 2019
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OBT076 Dose Escalation and Expansion
    OBT076 administered intravenously (IV) every 3 weeks in escalating dose cohorts during Part A and OBT076 administered at or below the MTD in the Part B expansion cohort. In Part C sequential administration of OBT076 administered at the recommended phase 2 dose (RP2D) followed by Balstilmab. Part D will evaluate the safety, tolerability, preliminary efficacy of OBT-076 in combination with Balstilmab. Part E will evaluate the safety, tolerability and preliminary efficacy of OBT076 as a triple combination regimen with balstilimab and gemcitabine in patients with metastatic NSCLC (Cohort E1) or locally-advanced/metastatic urothelial cancer Cohort E2)

Primary Outcome Measure

Incidence of Adverse Events (AEs) as assessed by NCI CTCAE (Version 5) [ Time Frame: 1 year ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85084-
Cedars-SinaiLos AngelesCalifornia90048-
UCLASanta MonicaCalifornia90404-
Moffitt Cancer CenterTampaFlorida33612-
The State University of IowaIowa CityIowa52242-
St. Elizabeth HealthcareEdgewoodKentucky41017-
University of Mississippi Medical CenterJacksonMississippi39216-
Quantum Santa FeSanta FeNew Mexico87505-
Columbia University Medical CenterNew YorkNew York10032-
University of PittsburghPittsburghPennsylvania15260-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic· Phoenix, AZCedars-Sinai· Los Angeles, CAUCLA· Santa Monica, CAMoffitt Cancer Center· Tampa, FLThe State University of Iowa· Iowa City, IASt. Elizabeth Healthcare· Edgewood, KY

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