OPB-101 for Ovarian Cancer

Recruiting at 2 trial locations

Overseen By John Ferraro

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Outpace Bio, Inc.

Must not be taking: High dose corticosteroids

Disqualifiers: Pregnancy, Infections, Autoimmune, Cancer, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OPB-101 for individuals with ovarian cancer that no longer responds to platinum-based chemotherapy. The main goals are to assess the safety of OPB-101 and determine the optimal dose. In this trial, participants will have their T cells (a type of immune cell) modified in a lab and returned to them in a one-time hospital treatment. Those whose ovarian cancer has returned after chemotherapy and who have tried at least two different treatments might be suitable candidates. Participants will receive close monitoring at the clinical site for the first few months after treatment. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you cannot be on high dose corticosteroids or have unresolved effects from prior therapies, so you might need to discuss your current medications with the trial team.

Is there any evidence suggesting that OPB-101 is likely to be safe for humans?

Research shows that OPB-101, a type of CAR T cell therapy, is being tested for safety in treating ovarian cancer that resists platinum-based treatments. OPB-101 modifies a patient's own T cells, part of the immune system, and then returns them to the patient to help fight the cancer.

This treatment remains in the early research stages, so information about its safety in humans is limited. However, this phase is crucial for assessing how well the treatment is tolerated and determining the right dose. Researchers closely monitor participants to observe their body's reactions and identify any side effects.

Although OPB-101 is not yet approved for any condition, early studies focus on ensuring its safety for people. Participants in these studies receive close monitoring to manage any side effects quickly. This process helps researchers gather the necessary safety data for future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for ovarian cancer, which typically involve chemotherapy, OPB-101 is unique because it introduces a new mechanism of action. Researchers are excited about OPB-101 because it targets specific cancer cell pathways, potentially leading to fewer side effects and improved effectiveness. This approach may offer hope for better outcomes, especially for patients who have not responded well to existing therapies.

What evidence suggests that OPB-101 might be an effective treatment for ovarian cancer?

Research has shown that OPB-101, the treatment under study in this trial, could be a promising therapy for ovarian cancer. It employs specially modified immune cells, known as T cells, to attack cancer. OPB-101 targets a protein called mesothelin, commonly found on cancer cells. Studies have indicated that OPB-101 shows fewer signs of T cell exhaustion, meaning the T cells remain active longer. It also enhances T cell strength and memory, potentially leading to a more robust and enduring fight against cancer. Although these results are preliminary, they offer encouraging signs of its potential effectiveness. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with ovarian cancer that hasn't responded to platinum-based chemotherapy. Participants will have their T cells modified and reinfused as a one-time treatment called OPB-101.

Inclusion Criteria

Alkaline phosphatase ≤ 2.5 x ULN

Negative screen for infectious disease markers

I agree to give a sample of my tumor for research.

Exclusion Criteria

Received investigational agents or tumor vaccines

I have received an organ or tissue transplant from another person.

I have not received a live vaccine in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time treatment of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy

1 day

1 visit (in-person, hospital stay)

Initial Follow-up

Participants are checked frequently at the clinical site for safety and efficacy monitoring

3 months

Frequent visits (in-person)

Extended Follow-up

Participants are monitored for long-term safety and determination of maximum tolerated dose

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• OPB-101

Trial Overview The study aims to determine the safety and optimal dose of OPB-101, where patients' T cells are engineered in a lab and reintroduced into their bodies to fight cancer.

How Is the Trial Designed?

Group I: OPB-101 Treatment Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Outpace Bio, Inc.

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07030907

A Study to Evaluate the Safety and Efficacy of OPB-101 in ... The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101.

2. jitc.bmj.com jitc.bmj.com/content/12/Suppl_2/A1205

1085 OPB-101: a mesothelin-specific CAR T cell therapy ... OPB-101 showed reduced levels of exhaustion markers (PD-1, TIGIT and CD39) and increased T cell stemness and memory populations. Conclusions ...

3. outpacebio.com outpacebio.com/news/outpace-bio-to-present-new-data-on-programmed-car-t-cell-candidate-opb-101-at-the-2024-society-for-immunotherapy-of-cancer-sitc-annual-meeting

Outpace Bio at SITC 2024: AI-powered OPB-101 CAR T ... Outpace Bio will share updated preclinical efficacy results for OPB-101, a mesothelin (MSLN)-specific chimeric antigen receptor (CAR) T cell.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07030907?term=SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DUnited%20States%20AND%20AREA%5BLocationState%5DMinnesota)&rank=5

A Study to Evaluate the Safety and Efficacy of OPB-101 in ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

5. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2025-0424.html

A phase 1a/b study to evaluate the safety and efficacy of ... The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101.

6. experts.umn.edu experts.umn.edu/en/projects/a-phase-1ab-study-to-evaluate-the-safety-and-efficacy-of-opb-101-

A phase 1a/b study to evaluate the safety and efficacy ... A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of ...