New biologic drug DBC-664 takes aim at Hard-to-Treat cancers
NCT ID NCT07705035
First seen Jul 15, 2026 · Last updated Aug 21, 2026 · Updated 4 times
Summary
This early-phase trial is testing an experimental biologic drug, DBC-664, in adults with advanced solid tumors such as ovarian, lung, and stomach cancers that have spread or come back. The study has two parts: first, finding a safe dose, and then expanding to see how well the drug works. The main goals are to check safety, measure how the drug moves through the body, and look for signs of tumor shrinkage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental biologic drug called DBC-664
- What this could lead to
- If successful, this could lead to a new treatment option for several types of advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early, first-in-human trial focused mainly on safety, so it is unknown whether DBC-664 will effectively shrink tumors or improve survival. Side effects are also not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 210 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Apr 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Must be ≥18 years of age at the time consent is signed. * Has a histologically or cytologically confirmed unresectable recurrent locally advanced or metastatic solid tumor * Has measurable disease per RECIST v1.1 (or mRECIST 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology. Exclusion Criteria: * Has a diagnosis of immunodeficiency. * Has had a prior stem cell, bone marrow, or organ transplant. * Has a known history of human immunodeficiency virus (HIV) infection. * Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. * Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * Has a history of (noninfectious) pneumonitis that required steroids or current active pneumonitis/interstitial lung disease. * Has symptomatic visceral spread of disease that poses a risk of life-threatening complications in the short term, per Investigator's opinion (including massive uncontrolled effusions \[pleural, pericardial, peritoneal\], pulmonary lymphangitis, and over 50% liver involvement). * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated CNS metastases may participate provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging \[note that the repeat imaging should be performed during study Screening\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. * Has a history of a previous secondary malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy or other localized, low-grade tumors deemed cured, or whose natural history does not have the potential to interfere with the safety or efficacy assessments of the current study and not treated with systemic anticancer therapy \[except hormonal therapy\]). * Has a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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SCRI Oncology Partners
RECRUITINGNashville, Tennessee, 37203, United States
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START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START New Jersey
RECRUITINGEast Brunswick, New Jersey, 08816, United States
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START New York
RECRUITINGLake Success, New York, 11402, United States
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Sarah Cannon Research Institute - Denver HealthONE
RECRUITINGDenver, Colorado, 80218, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A single arm, open label, dose-escalation phase i and dose-expansion phase IIa clinical study to evaluate the feasibility, safety, and efficacy of allogeneic chimeric antigen receptor (CAR) Gamma-Delta t cells CAR001 in subjects with Relapsed/Refractory solid tumors
- Operationalising multifactorial ovarian cancer risk assessment using the CanRisk tool versus standard practices.
- Can a new drug shrink advanced solid tumors?
- Can ultrasound sharpen the surgical map for ovarian cancer near the liver?
- Can a new drug shrink tumors that resist standard care?
- Can protein patterns in stored tumors point to new treatment targets?