81 Participants NeededMy employer runs this trial

NPX372 for Cancer

Recruiting at 5 trial locations
Tn
Overseen ByTrials nextpointtx
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 NPX372, an antibody drug designed to help the immune system target and destroy cancer cells. Researchers focus on ensuring NPX372's safety and determining the best dose for future studies. The study seeks individuals with recurring or widespread solid tumors, such as certain types of lung or ovarian cancer, that have not responded to standard treatments. Participants will receive NPX372 through an IV infusion and undergo close monitoring by doctors.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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, you cannot have had systemic anti-cancer treatment within 10 days before starting the study, and certain other treatments have specific waiting periods. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that NPX372 is likely to be safe for humans?

Research has shown that NPX372 has promising safety results from early studies. In preclinical trials, conducted in the lab before human testing, NPX372 was well-tolerated, meaning it did not cause serious side effects in the test models. It also effectively helped shrink tumors.

The studies indicate that NPX372 is safe at doses similar to those planned for humans. Importantly, there were no signs of cytokine release syndrome, a serious condition where the immune system overreacts.

As a Phase 1 trial, this is the first time NPX372 is tested in humans. This phase focuses on ensuring the treatment's safety. The positive preclinical results provide a good starting point, but the current trial will offer more information on how humans handle NPX372. Researchers will closely monitor participants to ensure their safety and determine the right dose for future studies.12345

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments like chemotherapy and radiation, NPX372 is unique because it is administered intravenously over 60 minutes, offering a potentially more targeted approach. Researchers are excited about NPX372 because it may work differently by targeting specific cancer cells with its novel formulation, potentially reducing side effects associated with traditional treatments. This makes NPX372 a promising option in the fight against cancer, as it could offer a more precise and effective treatment.

What evidence suggests that NPX372 might be an effective treatment for cancer?

Research has shown that NPX372, the investigational treatment in this trial, may help treat certain cancers. In lab studies, NPX372 activated immune cells called T cells, which then targeted and killed cancer cells with a specific protein, B7-H7, on their surface. In animal tests, NPX372 caused tumors to shrink completely and was well tolerated. These results suggest NPX372 could effectively enhance the body's immune response against tumors. Early findings also indicate it might slow tumor growth by affecting the formation of blood vessels around the tumor.13467

Who Is on the Research Team?

LG

Leena Gandhi, MD, Ph.D.

Principal Investigator

NextPoint Therapeutics, Inc.

Are You a Good Fit for This Trial?

This trial is for adults (19+) with certain advanced or recurring solid tumors—like lung, kidney, colon, pancreatic, bile duct, stomach/esophagus, or ovarian cancer—that have not responded to standard treatments. Participants need good organ function and overall health as measured by blood tests.

Inclusion Criteria

My hemoglobin level is at least 9.0 g/dL.
* Ability to understand and the willingness to sign a written informed consent document.
* Measurable disease by RECIST v1.1 criteria.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intravenous (IV) infusion of NPX372 and are closely monitored by the treating physicians

24 months
Following dose on Day 1 for Cycle 1 (21 days). Following dose on Day 1 for Cycles 2 through 7 (28 days). Following dose on Day 1 every 3 cycles up to the end of treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days
90-day follow-up after Cycle 7

What Are the Treatments Tested in This Trial?

Interventions

  • NPX372

Trial Overview

The study is testing NPX372, an antibody drug given by IV that aims to help the immune system attack cancer cells. The main goals are to find a safe dose and see how well it works in people with these cancers.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: NPX372Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NextPoint Therapeutics, Inc.

Lead Sponsor

Trials
2
Recruited
280+

Citations

NCT07563829 | NPX372, a B7-H7:CD3 Bispecific Antibody ...

NPX372 is being developed as a therapeutic in solid tumor malignancies including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), ...

Targeted T Cell Engager to Treat Solid Tumo

In preclinical studies, NPX372 demonstrated complete tumor regression in solid tumor models, while displaying great tolerability in relevant ...

Safety and tolerability of NPX372, a novel B7-H7:CD3 ...

The totality of the data suggests that NXP372 may be a safe and effective drug to further develop toward human clinical studies. References 1) ...

Abstract 4354: Safety and tolerability of NPX372, a novel B7 ...

NPX372 induced T cell activation and T cell-mediated killing of B7-H7+ tumor cells in vitro and B7-H7 levels correlated with cytotoxic potency.

NPX372, Novel T-Cell Engager in Solid Tumors, Gains IND ...

It is considered a promising immunotherapy target, with potential for boosting anti-tumor immunity and inhibiting tumor-related angiogenesis.

NextPoint Therapeutics Announces First-in-class T Cell ...

Preclinical data highlight. NPX372's potent anti-tumor responses and a favorable safety profile at clinically relevant doses with no ...

NPX372 / NextPoint

... data highlight NPX372's potent anti-tumor responses and a favorable safety profile at clinically relevant doses with no indication of cytokine release syndrome.