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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

Must not have

Subject has a history of, or current symptomatic brain metastasis

Subject has any ongoing skin disorders not controlled by specific treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have HER2 negative breast cancer and have received chemotherapy for it after it spread.

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I am fully active or can carry out light work.

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My tumor is CD205 positive.

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My cancer diagnosis was confirmed through tissue examination.

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I have hormone-receptor positive breast cancer and have had at least two prior endocrine therapies.

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I am 18 or older with cancer that has returned or spread and standard treatments have failed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have brain metastasis that causes symptoms.

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I have skin conditions that aren't managed by treatment.

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I have an ongoing eye condition or Sjogren's syndrome.

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I am a woman who can become pregnant.

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I cannot or will not take folic acid or vitamin B12 supplements.

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I have not had chemotherapy in the last 28 days.

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I have had serious heart problems in the last 6 months.

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I do not have cancer spread to the lining of my abdomen.

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I do not have colorectal or pancreatic cancer.

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I haven't had major surgery in the last 2 weeks or still have major side effects from it.

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I've had severe side effects from previous immunotherapy.

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I have not had any other cancer in the last 5 years.

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I have a history of serious lung conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Clearance (CL) of OBT076

Clinical Benefit Ratio (CBR)

+8 more

Other study objectives

Quantification of Immune Cells (ICs) in Tumor Microenvironment (TME)

Quantification of Peripheral Blood CD205+ Cells

Quantification of Serum Protein

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 19Eligibility criteria met