RecruitingMalignant Germ Cell TumorLung AdenocarcinomaGastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma
DBC-664 in Adult Patients With Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
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.
Sponsor: Duboce Biopharmaceuticals, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07705035 · last updated 2026-08-21