DBC-664 in Adult Patients With Solid Tumors

Study summary

DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedDBC-664

The study team can explain what participation involves.

Who it may be forMalignant Germ Cell Tumor · Lung Adenocarcinoma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 29, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Duboce Biopharmaceuticals, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Duboce Biopharmaceuticals, Inc.
Interventions being studied: Biological: DBC-664

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Sarah Cannon Research Institute - Denver HealthONEDenver, Colorado
START MidwestGrand Rapids, Michigan
START New JerseyEast Brunswick, New Jersey
START New YorkLake Success, New York
SCRI Oncology PartnersNashville, Tennessee
START San AntonioSan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 29, 2026. Always confirm current availability with the study team.

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