210 Participants NeededMy employer runs this trial

DBC-664 for Cancer

Recruiting at 4 trial locations
LK
Overseen ByLisa Knapp
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 DBC-664 to determine its safety and effectiveness for individuals with certain advanced cancers, including endometrial and ovarian cancer. In the first phase, researchers will determine the appropriate dose of DBC-664. In the second phase, they will study its effects on tumors. Suitable participants have advanced cancer that cannot be surgically removed and can be measured with imaging tests. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

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

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

Is there any evidence suggesting that DBC-664 is likely to be safe for humans?

A previous study tested DBC-664 on adults with advanced solid tumors to assess its safety and efficacy. Participants generally tolerated the treatment well, and researchers reported no major safety issues. However, since this marks the first human trial of DBC-664, all potential side effects remain under close observation. This study is in an early phase, so researchers primarily focus on ensuring the treatment's safety. Participants will help researchers understand how well patients with cancer can handle DBC-664.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about DBC-664 for cancer because it offers a novel approach compared to traditional treatments like chemotherapy and radiation. Unlike these standard treatments, which often target rapidly dividing cells indiscriminately, DBC-664 specifically targets cancer cells, potentially minimizing harm to healthy cells. This targeted mechanism could lead to fewer side effects and improved patient outcomes. Additionally, DBC-664's ability to precisely attack tumor cells may enhance its effectiveness, making it a promising candidate in cancer therapy.

What evidence suggests that DBC-664 might be an effective treatment for cancer?

Research has shown that DBC-664 exhibits early signs of tumor-fighting potential. In one study, about 45% of patients responded well to the treatment, with some experiencing complete tumor disappearance. This trial will evaluate DBC-664 in two parts: Part 1 will determine the recommended dose for expansion, and Part 2 will confirm the safety and anti-tumor activity at that dose. DBC-664 might help shrink or control tumors, offering hope for treating cancers like endometrial and ovarian cancer. Although these results are promising, DBC-664 remains in the early stages of research, and further studies are needed to fully understand its efficacy.678910

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors such as lung, prostate, bladder, stomach, endometrial, or ovarian cancer. Participants must meet specific health criteria and have cancers that are not responding to standard treatments.

Inclusion Criteria

I am 18 years old or older.
I have a confirmed advanced or metastatic solid tumor that cannot be removed by surgery.
I have tumors that can be measured on scans.

Exclusion Criteria

I have been diagnosed with an immune system deficiency.
My cancer has spread to organs and is causing serious, immediate health risks.
I have been diagnosed with HIV.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive DBC-664 to determine the recommended dose for expansion (RDE) regimen

1 year

Dose Expansion

Participants receive DBC-664 at the RDE to confirm safety and anti-tumor activity

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • DBC-664

Trial Overview

The study is testing a new drug called DBC-664 to see if it is safe and how well it works against various advanced cancers. The trial has two parts: first finding the best dose (Phase 1a), then further studying its effects at that dose (Phase 1b).

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part 2 (Dose Expansion)Experimental Treatment1 Intervention
Group II: Part 1 (Dose Escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duboce Biopharmaceuticals, Inc.

Lead Sponsor

Citations

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