Recruiting
Phase 1

DBC-664

Sponsor:

Duboce Biopharmaceuticals, Inc.

Code:

NCT07705035

Conditions

Malignant Germ Cell Tumor

Lung Adenocarcinoma

Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma

Urothelial Carcinoma

Endometrial Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DBC-664

Study Details

Brief 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.

Conditions

Malignant Germ Cell Tumor

Lung Adenocarcinoma

Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma

Urothelial Carcinoma

Endometrial Adenocarcinoma

Study ID

NCT07705035

Start date

Jul 17, 2026

Status verified date

Aug, 2026

Completion date

Apr 1, 2030

Anticipated

Primary completion date

Apr 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 (Dose Escalation)

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

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.

Interventions

DBC-664

DBC-664 will be administered intravenously.

Primary outcome measure

  • Safety and Tolerability [ Time Frame: 2 years ]
  • Determine Recommended Dose for Expansion [ Time Frame: 1 year ]
  • Characterize Pharmacokinetics [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Lisa Knapp

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

Locations

Sarah Cannon Research Institute - Denver HealthONE

Recruiting

Denver, Colorado, United States, 80218

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

START New York

Recruiting

Lake Success, New York, United States, 11402

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

More Information

Sponsor

Duboce Biopharmaceuticals, Inc.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Duboce Biopharmaceuticals, Inc. on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.