18 Participants NeededMy employer runs this trial

GB-5267 for Ovarian Cancer

AR
Overseen ByAsk RPCI
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GB-5267 for individuals with ovarian cancer unresponsive to platinum-based chemotherapy. The main goal is to assess the treatment's safety and effectiveness. Participants will receive the treatment either through an IV (a drip) or a combination of IV and another method called IP (into the abdomen). It suits those with confirmed ovarian, peritoneal, or fallopian tube cancer that has not improved with standard treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications like full-dose anticoagulants, high-dose steroids, and some immunosuppressants are not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GB-5267 is being tested for safety in treating ovarian cancer. This treatment targets a specific protein in cancer cells and appears safe and tolerable for patients so far. Patients can receive GB-5267 either through an IV (a drip into a vein) or a combination of IV and IP (directly into the abdomen) infusion.

In studies, GB-5267 has not shown any major safety concerns yet. However, it is important to note that this is a phase 1 study, meaning researchers are still closely observing how the treatment affects people. This phase marks the first step in testing a new treatment in humans, so unknown side effects may occur.

While the treatment is still in early testing, initial findings suggest it is well-tolerated by patients. Those considering joining a trial should know that safety is a top priority, and participants will be monitored closely for any side effects.12345

Why are researchers excited about this trial's treatments?

Unlike the standard chemotherapy treatments for ovarian cancer, which typically involve drugs like paclitaxel and carboplatin, GB-5267 offers a novel approach. Researchers are excited about GB-5267 because it uses a unique delivery method, administering the treatment both intravenously (IV) and intraperitoneally (IP), which could enhance the drug's effectiveness by targeting cancer cells directly in the abdominal cavity. This dual infusion approach may improve the treatment's reach and efficacy, potentially leading to better outcomes for patients who haven't responded well to traditional chemotherapy.

What evidence suggests that GB-5267 might be an effective treatment for ovarian cancer?

Research has shown that GB-5267 could be a promising treatment for ovarian cancer that doesn't respond to standard platinum-based treatments. This trial will evaluate GB-5267, a type of CAR T-cell therapy that uses specially altered immune cells to find and destroy cancer cells. It specifically targets MUC16, a protein often found on ovarian cancer cells. Participants in this trial will receive either an IV-only infusion or a combined IV and IP infusion of GB-5267. Early results suggest that this method might be safe and effective. Although still in the early stages, these findings offer hope for better treatment options for patients dealing with this challenging condition.12678

Who Is on the Research Team?

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Emese Zsiros, MD, PhD

Principal Investigator

Roswell Park Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with certain types of ovarian, peritoneal, or fallopian tube cancer that has come back or gotten worse within 6 months after platinum-based chemo, or who can't tolerate more platinum treatment. Participants need to be in good general health and have working kidneys and enough blood cells.

Inclusion Criteria

Must agree to use effective contraception from infusion until at least 1 year post-infusion
Ability and willingness to adhere to study visit schedule and protocol requirements
Must understand investigational nature and sign approved informed consent form prior to any study procedure
See 13 more

Exclusion Criteria

I do not have an active infection needing IV antibiotics, antivirals, or antifungals.
I have not had any other active cancer in the past 2 years, except certain skin cancers.
I do not need urgent treatment for my tumor that would prevent me from following the study plan.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients receive IV only infusion of GB-5267 cells. Dose escalation continues until Maximum Tolerated Dose (MTD) is established.

4 weeks
Weekly visits for dose escalation monitoring

Dose Expansion

Combined administration of both IV and IP infusions to assess enhanced local antitumor effects.

Up to 2 years
Regular visits for infusion and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • GB-5267

Trial Overview

The study is testing a new drug called GB-5267 given by IV alone or both IV and directly into the abdomen (IP) to see if it's safe and effective for treating platinum-resistant ovarian cancer.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: IV OnlyExperimental Treatment1 Intervention
Group II: Dose Expansion with Combined IV and IP InfusionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

Generate Biomedicines

Industry Sponsor

Citations

GB-5267 for the Treatment Platinum-Resistant Ovarian ...

Giving GB-5267 may be safe, tolerable and/or effective in treating patients with ovarian, peritoneal or fallopian tube cancer that is platinum-resistant.

Research & Clinical Trials Search Results: Ovarian Cancer

GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer. NCT06526819, SMP-3124LP in Adults With Advanced Solid Tumors.

Ovarian cancer clinical trial endpoints: Society of Gynecologic ...

... ovarian cancer has improved from 26.8% in 1958 to 49.7% in 2001 [4]. Similarly, administrative data show that the 5-year relative ovarian cancer survival ...

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This study is to test the hypothesis that the combination of Olvi-Vec followed by further chemotherapy is particularly effective against established tumors by ...

GB-5267 for the Treatment Platinum-Resistant Ovarian ...

This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer.

GB-5267 for the Treatment Platinum-Resistant Ovarian, ...

This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer. Key Facts. Lead ...

GB-5267 for the Treatment Platinum-Resistant Ovarian ...

This phase 1 study evaluates the safety, efficacy, and biological activity of GB-5267 in patients with platinum-resistant ovarian cancer. Check your ...

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