OBT076 for Advanced Cancer

Recruiting at 22 trial locations

Overseen By Medical Monitor

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Oxford BioTherapeutics Ltd

Must not be taking: Chemotherapy, Anticancer therapy

Disqualifiers: Colorectal, Pancreatic, Brain metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 21 days per cycle

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any chemotherapy or other systemic anticancer therapy at least 28 days before starting the study drug. The protocol does not specify about other medications, so it's best to discuss your current medications with the study team.

What is the purpose of this trial?

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.

Research Team

Rutika Mehta

Principal Investigator

Moffitt Cancer Center

Gary Schwartz, MD

Principal Investigator

Columbia University

Lee Rosen, MD

Principal Investigator

University of California, Los Angeles

Monica Mita, MD

Principal Investigator

Cedars-Sinai

Olivier Rixe, MD

Principal Investigator

Quantum Santa Fe

Eligibility Criteria

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.

Inclusion Criteria

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

I am fully active or can carry out light work.

I have had chemotherapy before surgery or as an additional treatment.

Exclusion 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OBT076 in 21-day cycles, with dose escalation and expansion phases

21 days per cycle

1 visit every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

• OBT076

Trial Overview 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.

Participant Groups

Group I: OBT076 Dose Escalation and Expansion Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Oxford BioTherapeutics Ltd

Lead Sponsor

Trials

1

Recruited

200+