Your session is about to expire
← Back to Search
Antibody-Drug Conjugate
OBT076 for Advanced Cancer
Phase 1
Recruiting
Led By Rutika Mehta, MD
Research Sponsored by Oxford BioTherapeutics Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject with recurrent locally advanced or metastatic non-curative HER2 negative breast cancer, must have received at least one prior line of cytotoxic chemotherapy in the metastatic setting
Subject has an ECOG performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying a new cancer drug, OBT076, to see if it is safe and effective. OBT076 is made of an antibody that targets the CD205 protein on cancer cells and delivers an anti-cancer drug which can kill them. Researchers will test different doses of OBT076 to find the highest dose that is safe and still works against the cancer.
Who is the study for?
Adults with non-curable recurrent/metastatic solid tumors positive for CD205, who've exhausted standard treatments or find them ineffective. Participants must have good organ and bone marrow function, an ECOG performance status of 0-1, measurable disease by radiology, and a maximum of two prior chemotherapy lines in the metastatic setting (up to five if last was over 12 weeks ago). Men must agree to contraception during the study and four months after; women of childbearing potential need a negative pregnancy test and use birth control.Check my eligibility
What is being tested?
OBT076 is being tested for safety and preliminary effectiveness against solid tumors. It's an investigational antibody-drug conjugate targeting CD205 on cancer cells. This Phase I trial aims to determine the highest safe dose level that doesn't cause unacceptable side effects while assessing its anti-cancer properties in participants at optimal doses.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions which can range from mild discomfort to more severe symptoms at the site of injection or systemic responses like fever or chills, fatigue, digestive issues including nausea or diarrhea, blood disorders like low counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have HER2 negative breast cancer and have received chemotherapy for it after it spread.
Select...
I am fully active or can carry out light work.
Select...
My tumor is CD205 positive.
Select...
My cancer diagnosis was confirmed through tissue examination.
Select...
I have hormone-receptor positive breast cancer and have had at least two prior endocrine therapies.
Select...
I am 18 or older with cancer that has returned or spread and standard treatments have failed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events (AEs) as assessed by NCI CTCAE (Version 5)
Percentage of subjects with dose-limiting toxicities (DLTs) as assessed by NCI CTCAE (Version 5)
Secondary outcome measures
Area under the Plasma Concentration versus Time Curve (AUC) of OBT076
Clearance (CL) of OBT076
Clinical Benefit Ratio (CBR)
+8 moreOther outcome measures
Quantification of Immune Cells (ICs) in Tumor Microenvironment (TME)
Quantification of Peripheral Blood CD205+ Cells
Quantification of Serum Protein
Trial Design
1Treatment groups
Experimental Treatment
Group I: OBT076 Dose Escalation and ExpansionExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Oxford BioTherapeutics LtdLead Sponsor
Rutika Mehta, MDPrincipal InvestigatorMoffitt Cancer Center
Olivier Rixe, MDPrincipal InvestigatorQuantum Santa Fe
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have brain metastasis that causes symptoms.I have skin conditions that aren't managed by treatment.I have an autoimmune disease that needed treatment in the last 3 years.I have HER2 negative breast cancer and have received chemotherapy for it after it spread.I had radiotherapy less than 4 weeks ago before starting the study drug.I am fully active or can carry out light work.I have had chemotherapy before surgery or as an additional treatment.I have an ongoing eye condition or Sjogren's syndrome.I have HIV but am on effective treatment with an undetectable viral load.I am a woman who can become pregnant.My bone marrow is functioning well.You have a disease that can be measured using medical imaging.I agree to use contraception and not father a child during and for 4 months after the study.I am not pregnant, will test before treatment, and will use effective birth control during and for 4 months after the study.I cannot or will not take folic acid or vitamin B12 supplements.You have had an organ transplant from another person.I am still experiencing side effects from previous cancer treatments or surgeries.I have not had chemotherapy in the last 28 days.I have had serious heart problems in the last 6 months.My tumor is CD205 positive.My organs are functioning well.I do not have cancer spread to the lining of my abdomen.I haven't had cancer treatment in the last 28 days or 5 half-lives before starting this trial.I do not have colorectal or pancreatic cancer.I haven't had major surgery in the last 2 weeks or still have major side effects from it.I got a COVID-19 vaccine less than a week before starting treatment.My cancer diagnosis was confirmed through tissue examination.I have hormone-receptor positive breast cancer and have had at least two prior endocrine therapies.I am 18 or older with cancer that has returned or spread and standard treatments have failed.I've had up to 5 previous chemotherapy treatments for my cancer that has spread, with the last one over 12 weeks ago.I've had severe side effects from previous immunotherapy.I have not had any other cancer in the last 5 years.You have any condition that makes it hard to understand the study results.I have a history of serious lung conditions.I need chemotherapy for a severe internal organ issue, as decided by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: OBT076 Dose Escalation and Expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals can participate in this trial at one time?
"A total of 150 suitable participants must be sourced for the trial. Oxford BioTherapeutics Ltd is overseeing this scientific endeavour, with clinical sites located in Jackson, Mississippi and Santa Monica, California."
Answered by AI
In what geographic areas is this clinical trial available?
"This trial is being conducted at the University of Mississippi Medical Centre in Jackson, UCLA in Santa Monica, and Rutika Mehta's practice in Tampa. Additionally, there are 4 other locations where this medical study is taking place."
Answered by AI
Are there vacancies available for enrolment in this clinical trial?
"According to clinicaltrials.gov, this research trial is presently looking for participants. It was initially made available on July 25th 2019 and most recently updated October 19th 2022."
Answered by AI
What objectives is this research endeavor hoping to achieve?
"This clinical trial will span a year and its primary outcome is the Percentage of participants suffering from dose-limiting toxicities (DLTs), as determined through NCI CTCAE Version 5. Secondary outcomes include data related to Duration of Response, Clearance, and Half-Life for OBT076 assessed using several statistical methods."
Answered by AI
To what extent can OBT076, a CD205-directed antibody-drug conjugate, be harmful to patients?
"Due to the Phase 1 status of OBT076, a CD205-directed antibody drug conjugate, our team at Power judged its safety as a score of one. This is because there is currently limited data available regarding both efficacy and safety."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger