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NCT07705035From ClinicalTrials.govRecruiting

DBC-664 in Adult Patients With Solid Tumors

A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of DBC-664 in Adult Patients With Locally Advanced or Metastatic Solid Tumors

  • Malignant Germ Cell Tumor
  • Lung Adenocarcinoma
  • Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Urothelial Carcinoma
  • Endometrial Adenocarcinoma
  • Ovarian Adenocarcinoma

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Duboce Biopharmaceuticals, Inc.
Enrolment target
210
Started
17 July 2026
Main results due
1 April 2030
Study sites
6
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(6)

  • Sarah Cannon Research Institute - Denver HealthONE

    Denver, Colorado, United States

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, United States

    Recruiting

  • START New Jersey

    East Brunswick, New Jersey, United States

    Recruiting

  • START New York

    Lake Success, New York, United States

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, United States

    Recruiting

  • START San Antonio

    San Antonio, Texas, United States

    Recruiting

Showing 6 of 6 sites. 6 of the 6 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07705035. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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DBC-664 in Adult Patients With Solid Tumors | Trialion