149 Participants NeededMy employer runs this trial

E303 for Cancer

Recruiting at 6 trial locations
SB
Overseen BySamsung Bioepis
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Samsung Bioepis Co., Ltd.
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 E303 for its safety and effectiveness in people with advanced solid tumors, which originate in solid organs or tissues. The main goal is to determine if E303 can benefit those whose cancer has returned or worsened after other treatments. Eligible participants have cancer that cannot be surgically removed or has spread, and they have tried, cannot tolerate, or refuse standard treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that the treatment E303 is in the early testing phase, known as Phase 1. This phase checks the treatment's safety and how well people can tolerate it. E303 is a new experimental treatment designed to target certain proteins in solid tumors. Since it is still in the first stage of human testing, clear information about its safety is not yet available. Researchers are beginning to learn how people react to it and what side effects might occur. Prospective participants should understand that the treatment is experimental and discuss any questions or concerns with the trial coordinators.12345

Why do researchers think this study treatment might be promising?

E303 is unique because it potentially targets cancer cells in a novel way that current treatments don't. While most cancer therapies, like chemotherapy and radiation, attack fast-growing cells indiscriminately, E303 aims to specifically target and disrupt cancer cell pathways, minimizing damage to healthy cells. This specificity could lead to fewer side effects and improved quality of life for patients. Researchers are excited about E303 because it represents a shift towards precision medicine, which is hoped to be more effective and safer for cancer patients.

What evidence suggests that E303 might be an effective treatment for cancer?

Research has shown that the treatment E303, which targets a protein called nectin-4, is under study for its potential to treat advanced solid tumors. Early results suggest that similar treatments, such as enfortumab vedotin (EV) combined with pembrolizumab, have produced promising outcomes in other cancers. Specifically, this combination significantly improved survival rates and maintained quality of life for patients with bladder cancer. E303 aims to work similarly by delivering potent cancer-fighting drugs directly to tumor cells while sparing healthy cells. Although further research is necessary, early indications are hopeful that E303 could enhance outcomes for individuals with advanced cancers.56789

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have come back or worsened after standard treatments, can't tolerate them, refused them, or have no other options. People with active autoimmune diseases, certain brain or nerve conditions, serious heart problems, or major bleeding issues cannot join.

Inclusion Criteria

My advanced or metastatic cancer has come back or worsened after standard treatment.

Exclusion Criteria

Have an active autoimmune disease
I have cancer that has spread to the lining of my brain or spinal cord.
I have serious heart or blood vessel disease.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the nectin-4 targeting antibody-drug conjugate (SBE303) for safety and efficacy evaluation

32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • E303

Trial Overview

The study is testing the safety and effects of a new drug called E303 (an antibody-drug conjugate targeting nectin-4) in people with advanced solid tumors. This is an early-phase (Phase I) clinical trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: E303Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Samsung Bioepis Co., Ltd.

Lead Sponsor

Trials
32
Recruited
9,900+

Citations

Assessing the patient reported outcomes (PROs) of ... - PMC

The investigational arm of EV + pembrolizumab showed a 15.4-month (53% relative improvement) increase in overall survival and 6.2 months increase in progression ...

Phase III EV-303/KEYNOTE-905 Shows Padcev Plus ...

Key efficacy results from EV-302/KEYNOTE-A39 · Padcev plus Keytruda reduced the risk of death by 49% compared to chemotherapy alone (HR 0.51; 95% ...

PADCEV TM Plus KEYTRUDA TM Significantly Improves ...

These EV-303 study results mark the first time a systemic treatment approach, used before and after surgery, significantly extended survival ...

ASCO 2023: KEYNOTE-905/EV-303: A Phase 3 Study to ...

A phase 3 study evaluating the efficacy and safety of perioperative pembrolizumab or pembrolizumab + enfortumab vedotin for MIBC.

Patient-Reported Outcomes in Patients With Advanced ...

PRO findings showed that EV + P was associated with preservation or improvement of QOL, emotional functioning, pain, insomnia, and constipation, ...

E303 for Cancer · Recruiting Participants for Phase ...

This is a Phase I trial to evaluate the safety, tolerability and efficacy of nectin-4 targeting antibody-drug conjugate (SBE303) in ...

A Trial to Investigate the Safety of E303 in Participants With ...

This is a Phase I trial to evaluate the safety, tolerability and efficacy of nectin-4 targeting antibody-drug conjugate (SBE303) in ...

Trial Data Show Significant EFS and OS in Patients with ...

New trial results reveal that combining pembrolizumab and enfortumab vedotin significantly enhances survival rates in muscle-invasive bladder ...

NCT07313891 | A Study of Adjuvant NDV-01 (Sustained ...

A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Following TURBT (BOOST).