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RecruitingNCT07705035Updated Sep 29, 2026

DBC-664 in Adult Patients With Solid Tumors

A Phase 1 interventional study of DBC-664 in Malignant Germ Cell Tumor, Lung Adenocarcinoma and Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, sponsored by Duboce Biopharmaceuticals, Inc.. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Duboce Biopharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
210
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Malignant Germ Cell Tumor
  • Lung Adenocarcinoma
  • Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Urothelial Carcinoma
  • Endometrial Adenocarcinoma
  • Ovarian Adenocarcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Part 1 (Dose Escalation)

    Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen.

    Biological: DBC-664

  • Experimental
    Part 2 (Dose Expansion)

    Participants will receive DBC-664 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity.

    Biological: DBC-664

Interventions

  • BiologicalDBC-664

    DBC-664 will be administered intravenously.

05

What researchers measure

Primary outcomes

  1. Safety and Tolerability

    The safety and tolerability of DBC-664 in patients with solid tumor measured by frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), adverse events of special interest (AESIs), adverse events (AEs) leading to dose interruption and of adverse events (AEs) leading to treatment discontinuation

    Time frame: 2 years

  2. Determine Recommended Dose for Expansion

    To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE\[s\]) of DBC-664

    Time frame: 1 year

  3. Characterize Pharmacokinetics

    To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration

    Time frame: 2 years

06

Study locations

6 of 6 sites recruiting
  • Sarah Cannon Research Institute - Denver HealthONE
    Denver, Colorado 80218, United States
    Recruiting
  • START Midwest
    Grand Rapids, Michigan 49546, United States
    Recruiting
  • START New Jersey
    East Brunswick, New Jersey 08816, United States
    Recruiting
  • START New York
    Lake Success, New York 11402, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee 37203, United States
    Recruiting
  • START San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07705035
Lead sponsor
Duboce Biopharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jul 15, 2026
Start date
Jul 17, 2026
Primary completion
Apr 1, 2030 (estimated)
Completion
Apr 1, 2030 (estimated)
Last update
Sep 29, 2026

Study contacts

Lisa Knapp
Contact
lknapp@tcglsoleil.com
+1 (650) 442-3367

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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