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Solid TumorPhase 1NCT04064359

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

A Phase 1 study testing OBT076, a CD205-directed antibody-drug conjugate in people with Solid Tumor, run by Oxford BioTherapeutics Ltd at 27 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
OBT076, a CD205-directed antibody-drug conjugate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
27 sitesin 5 countries
Study dates
25 Jul 2019to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Subject has histologically and/or cytologically confirmed solid tumors.
  • Subject with Breast cancer:
  • 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
  • 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+.
  • Subject with triple negative breast cancer are eligible after at least one prior line of cytotoxic chemotherapy in the metastatic setting.
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  • Subject with prior adjuvant or neoadjuvant chemotherapy allowed.
  • 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
  • Subject has tumor that is positive for CD205 antigen by IHC staining
  • Subject has an ECOG performance status of 0-1.
  • Subject has radiological documented measurable disease (i.e., at least 1 measurable lesion as per RECIST Version 1.1).
  • Subject has adequate organ function
  • Subject has adequate bone marrow function
  • Subject understands and voluntarily signs an ICD prior to any study-related assessments/procedures are conducted.
  • Subject is able to adhere to the study visit schedule and other protocol requirements.
  • Subject who is a female of childbearing potential (defined as a sexually mature women, has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal for at least 12 consecutive months and is using any adequate form of birth control must:
  • Have a negative pregnancy test within 1 week before first dose of study drug.
  • Use highly effective method(s) of birth control consistently and correctly during the study and for at least 4 months after the last dose of study drug.
  • Agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 4 months after the last dose of study.
  • Agree to no plan to breastfeed and no plan to become pregnant during the study and for at least 4 months after the last dose of study drug.
  • Subject who is a sexually active male must agree to use a condom, not to donate sperm and have no plans to father a child during the study and for at least 4 months after the last dose of study drug.

Who cannot join

  • Subject has received any chemotherapy within 28 days prior to Cycle 1 Day 1.
  • Subject has received any other systemic anticancer therapy within 28 days or 5 half-lives of Cycle 1 Day 1.
  • Subject has symptomatic visceral crisis requiring chemotherapy per Investigator judgment for non TNBC.
  • Subject with colorectal cancer and pancreatic cancer are not eligible for the study.
  • Subject with peritoneal involvement, i.e., peritoneal carcinomatosis, are not eligible for the study.
  • 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).
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  • Subject has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
  • Subject has had radiotherapy ≤ 4 weeks prior to starting study drug.
  • Subject has a history of, or current symptomatic brain metastasis.
  • Subject has any other malignancy within 5 years prior to randomization
  • Subject has a known or suspected hypersensitivity or other contraindication to any excipients used in the manufacture of OBT076.
  • Subject has significant medical condition, laboratory abnormality, or psychiatric illness that would, in the Investigator's judgment, contraindicate patient participation in the study (e.g., history of thromboembolic event, cardiac dysfunction, chronic pancreatitis, chronic active hepatitis)
  • Subject has severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine <7 days before Cycle 1 Day 1
  • Subject has any condition that confounds the ability to interpret data from the study.
  • Subject is lactating or breastfeeding.
  • Subject has a past medical history of or ongoing clinically relevant interstitial lung disease, drug-induced pneumonitis or severe/very severe COPD.
  • Subject has active or chronic corneal disorder or Sjogren's syndrome.
  • Subject has any ongoing skin disorders not controlled by specific treatment.
  • Subject has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or NYHA class 3 or 4 congestive heart failure, or patients with QTc interval >470ms at screening.
  • Subject has a known history or current diagnosis of HIV infection, unless on triple antiviral treatment with undetectable viral load.
  • Subject who is female of childbearing potential
  • Subject who is unable or unwilling to take folic acid or vitamin B12 supplementation.
  • Subject with a history of allogeneic organ transplant.
  • Subject with grade 3 or 4 immune-related adverse reactions during any prior line of checkpoint inhibitor containing therapy. Patients with immune-related thyroiditis controlled with substitution, or prior asymptomatic lipase increases are eligible for the study.
  • Subject with active autoimmune disease or history of autoimmune disease that required systemic treatment within 3 years of the start of study treatment.
  • Additional inclusion criteria specific for Part E:
  • 1. Patients with stage IV NSCLC or stage III/stage IV urothelial cancer who have progressed on standard treatments or for whom a standard therapy is not available, standard therapy is no longer effective, or who have no satisfactory treatment options.
  • Additional exclusion criteria for Part E:
  • The presence of any contraindication to gemcitabine as per applicable Summary of Product Characteristics/label.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) within the 14 days prior to the first dose of study treatment or another immunosuppressive medication within the 30 days prior to the first dose of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses )\ mg daily prednisone equivalent) are permitted in the absence of active autoimmune disease.
  • Patients with urothelial cancer and any history or current CNS metastasis.
  • Patients who were hospitalized during screening for infectious complications or required IV antibiotics in the 14 days prior to Cycle 1 Day 1.
  • Patients who presented in the 14 days prior to or on Cycle 1 Day 1 with one or more of the following:
  • ANC of <1.5 x 109 cells/L
  • Platelets of < 100 x 109 cells/L
  • Hemoglobin of < 9 g/dL
  • Patients who received G-CSF in the 14 days prior to Cycle 1 Day 1
  • Patients who had febrile neutropenia during the previous line of therapy or during the last line of therapy containing cytotoxic chemotherapy.
  • Patients who are primary refractory to anti-PD-(L)1 directed therapy.
  • Patients with NSCLC and more than 2 prior lines of systemic anti-cancer therapy in the locally-advanced/metastatic disease setting; and who received more than one prior line of cytotoxic chemotherapy in the locally-advanced/metastatic setting.
  • Patients with urothelial cancer who received more than 3 prior lines of systemic anti cancer therapy in locally-advanced/metastatic disease setting. Prior neoadjuvant or adjuvanttherapy is not counted.

Trial locations and contacts

27 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Medical Monitor contact

+44 (0)1235 861770

OBT076-001@oxfordbiotherapeutics.com

27 sites in 5 countries

United States10 sites

  • St. Elizabeth Healthcare

    Edgewood, Kentucky, 41017

    Completed

  • The State University of Iowa

    Iowa City, Iowa, 52242

    Active, not recruiting

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

    Completed

  • Cedars-Sinai

    Los Angeles, California, 90048

    Completed

  • Columbia University Medical Center

    New York, New York, 10032

    Completed

  • Mayo Clinic

    Phoenix, Arizona, 85084

    Completed

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

    Completed

  • Quantum Santa Fe

    Santa Fe, New Mexico, 87505

    Completed

  • UCLA

    Santa Monica, California, 90404

    Completed

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Completed

Other trials in United States

France7 sites, 6 recruiting

  • Institut Paoli Calmettes

    Marseille

    Recruiting

  • GHP Saint-Joseph

    Paris

    Clinical Trials

    Recruiting

  • Hopital Saint Antoine

    Paris

    Completed

  • Hopital Saint Louis

    Paris

    Clinical Trials

    Recruiting

  • Centre Eugène Marquis

    Rennes

    Clinical Trials

    Recruiting

  • ICANS - Institut de cancérologie Strasbourg

    Strasbourg

    Clinical Trials

    Recruiting

  • Institut Gustave Roussy - IGR

    Villejuif

    Recruiting

Other trials in France

Greece5 sites, 3 recruiting

  • Metropolitan Hospital

    Athens

    Completed

  • Sotiria General Hospital

    Athens

    Clinical Trials

    Recruiting

  • University General Hospital Attikon

    Chaïdári, Athens, 12462

    Anastasia Marangeli

    302105831643

    Recruiting

  • University General Hospital of Heraklion

    Heraklion

    Clinical Trials

    Recruiting

  • EuroMedica

    Thessaloniki, GR-54645

    Completed

Other trials in Greece

Spain3 sites, 3 recruiting

  • START Barcelona HM Nou Delfos

    Barcelona, 08023

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    Recruiting

  • University Hospital Marqués de Valdecilla

    Santander, 39008

    Recruiting

Other trials in Spain

Belgium2 sites, 1 recruiting

  • Institut Jules Bordet

    Brussels

    Clinical Trials

    Recruiting

  • AZ Groeninge

    Kortrijk

    Completed

Other trials in Belgium

About this study

Official title: A Phase I, Open-label, Dose Finding Study to Assess the Safety, Tolerability, PK, and Preliminary Efficacy of OBT076, a CD205-directed ADC, in Recurrent and/or Metastatic CD205+ Solid Tumors

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.

Read the detailed description

Study OBT076-001 is an open-label, Phase I, dose escalation and expansion clinical study of OBT076 in CD205+ve recurrent and/or metastatic solid tumors that are refractory to standard treatments, or for which a standard therapy is not available or not suitable or is no longer effective. The study will consist of four parts:

  • Part A: Dose escalation
  • Part B: OBT076 single agent expansion
  • Part C: Sequential administration of OBT076 and balstilimab
  • Part D: Combination therapy with concurrent administration of OBT076 and balstilimab• Part E: Triple combination therapy with concurrent administration of OBT076, balstilimab and gemcitabine in two cohorts of patients with metastatic NSCLC or locally-advanced/metastatic urothelial cancer.

Parts A, B, C, D will and E consist mainly of 3 periods: Screening, Treatment and Follow-up periods. The treatment period with OBT076 consists of 21 days cycles. Approximately 200 patients will be enrolled across Parts A to E.

Conditions
Solid Tumor
Being tested
OBT076, a CD205-directed antibody-drug conjugate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OBT076, a CD205-directed antibody-drug conjugateDrug

    Also called MEN1309

    Intravenous (IV) infusion of OBT076 every 3 weeks.

Study groups in NCT04064359
Study groupRoleWhat they receive
OBT076 Dose Escalation and ExpansionExperimentalOBT076 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)
Receives: Drug: OBT076, a CD205-directed antibody-drug conjugate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs) as assessed by NCI CTCAE (Version 5)

    Assess incidence of all AEs by NCI CTCAE (Version 5) grades 1-5

    Measured: 1 year

  2. Percentage of subjects with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE (Version 5)

    DLTs defined by NCI CTCAE (Version 5) grades 3-4, with exceptions for duration

    Measured: 1 year

Secondary outcomes (11)

  1. Clinical Benefit Ratio (CBR)

    RECIST, Version 1.1

    Measured: 2 years

  2. Overall Response Rate (ORR)

    RECIST, Version 1.1

    Measured: 2 years

  3. Duration of Response (DoR)

    Kaplan-Meier methodology

    Measured: 2 years

  4. Progression Free Survival (PFS)

    Kaplan-Meier methodology

    Measured: 2 years

  5. Overall Survival (OS)

    Kaplan-Meier methodology

    Measured: 2 years

  6. Area under the Plasma Concentration versus Time Curve (AUC) of OBT076

    Statistics including number of subjects (N), mean, standard deviation, CV%, geometric mean, geometric CV%, median, minimum, and maximum will be provided for OBT076

    Measured: 1 year

  7. Maximum Plasma Concentration [Cmax] of OBT076

    Statistics including number of subjects (N), mean, standard deviation, CV%, geometric mean, geometric CV%, median, minimum, and maximum will be provided for OBT076

    Measured: 1 year

  8. Time Taken to Reach the Maximum Plasma Concentration [Tmax] of OBT076

    Statistics including number of subjects (N), mean, standard deviation, CV%, geometric mean, geometric CV%, median, minimum, and maximum will be provided for OBT076

    Measured: 1 year

  9. Half-Life [T1/2] of OBT076

    Statistics including number of subjects (N), mean, standard deviation, CV%, geometric mean, geometric CV%, median, minimum, and maximum will be provided for OBT076

    Measured: 1 year

  10. Clearance (CL) of OBT076

    Statistics including number of subjects (N), mean, standard deviation, CV%, geometric mean, geometric CV%, median, minimum, and maximum will be provided for OBT076

    Measured: 1 year

  11. Volume of Distribution (Vd) of OBT076

    Statistics including number of subjects (N), mean, standard deviation, CV%, geometric mean, geometric CV%, median, minimum, and maximum will be provided for OBT076

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2019
  2. Study start25 Jul 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04064359
Sponsor's protocol ID
OBT076-001
Status last verified
Sep 2025
First submitted
16 Aug 2019
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OBT076, a CD205-directed antibody-drug conjugate in people with Solid Tumor, run by Oxford BioTherapeutics Ltd at 27 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, France, Greece, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Monitor (+44 (0)1235 861770, OBT076-001@oxfordbiotherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (AEs) as assessed by NCI CTCAE (Version 5) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04064359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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