DBC-664 in Adult Patients With Solid Tumors

Recruiting now · Phase 1

Conditions studied: Malignant Germ Cell Tumor, Lung Adenocarcinoma, Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, Urothelial Carcinoma, Endometrial Adenocarcinoma, Ovarian Adenocarcinoma

In brief

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.

Key facts

Study ID: NCT07705035
Run by: Duboce Biopharmaceuticals, Inc.
People needed: 210
Starts: 2026-06-17
Expected to finish: 2030-04-01
Last updated by the study team: 2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
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.

Where it is running

START Midwest — Grand Rapids, Michigan, United States (enrolling)
START New Jersey — East Brunswick, New Jersey, United States (enrolling)
START New York — Lake Success, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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