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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    70
  • sponsor
    Oxford BioTherapeutics Ltd
Updated on 27 October 2022
cancer
measurable disease
breast cancer
HER2
cancer treatment
antineoplastic
erbb2
cish
chromogenic in situ hybridization

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). 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.

Description

Study OBT076-001 is an open-label, Phase I, dose escalation and expansion clinical study of OBT076, a CD205-directed ADC, in recurrent and/or metastatic CD205+ve solid tumors. Part A, the dose escalation phase of the study, will explore escalating IV doses to determine the maximum tolerated dose (MTD) of OBT076. Approximately 20 subjects will be included in Part A of the study. Part B, the expansion phase of the study, will further evaluate the safety and preliminary efficacy of OBT076 administered at or below the MTD in expansion cohorts. Approximately 50 subjects will be enrolled in Part B. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

Details
Condition Solid Tumor
Treatment OBT076, a CD205-directed antibody-drug conjugate
Clinical Study IdentifierNCT04064359
SponsorOxford BioTherapeutics Ltd
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 has recurrent and/or metastatic cancer (based on most recently analyzed biopsy) defined by ASCO-CAP guidelines as negative in situ hybridization test or an IHC status of 0, 1+, or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing
Prior treatment with checkpoint inhibitors is allowed
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

Exclusion Criteria

Subject has received any chemotherapy within 21 days prior to inclusion in the study
Subject has received another investigational therapy within 28 days
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)
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 severe renal impairment (creatinine clearance < 30 mL/min)
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 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
Subject has a known history or current diagnosis of HIV infection, unless on triple antiviral treatment with undetectable viral load
Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would, in the Investigator's judgment, contraindicate subject participation in the study (e.g., history of thromboembolic event, cardiac dysfunction, chronic pancreatitis, chronic active hepatitis)
Subject has any condition that confounds the ability to interpret data from the study
Subject is a female of childbearing potential
Subject is lactating or breastfeeding
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note