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NCT07705035RecruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 27 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
210 (estimated)
First submitted
29 Jun 2026
Start date
17 Jul 2026
Primary completion date
1 Apr 2030
Lead sponsor
Duboce Biopharmaceuticals, Inc.
NCT number
NCT07705035

What you commit to

  • Study type: Interventional · Phase 1
  • Planned participants: 210
  • From 17 Jul 2026 to the primary completion date, 1 Apr 2030
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has had a prior stem cell, bone marrow, or organ transplant.
  • 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 \[except hormonal therapy\]).

Other illness

  • 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 a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.

Other

  • Has a diagnosis of immunodeficiency.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sarah Cannon Research Institute - Denver HealthONE
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
START - New Jersey
Coordinator of this site? Confirm its status
East BrunswickUnited StatesRecruiting
START | Midwest
Coordinator of this site? Confirm its status
Grand RapidsUnited StatesRecruiting
START New York
Coordinator of this site? Confirm its status
Lake SuccessUnited StatesRecruiting
SCRI Oncology Partners
Coordinator of this site? Confirm its status
NashvilleUnited StatesRecruiting
START | San Antonio
Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting
Washington University School of Medicine
Coordinator of this site? Confirm its status
St LouisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.