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DBC-664 for Advanced Solid Tumors

This study is testing a new immunotherapy called DBC-664 in adults with advanced solid tumors, including certain types of lung, stomach, bladder, and endometrial cancers. The main goals are to understand how safe DBC-664 is, what side effects it might cause, and to find the best dose. Researchers will also look at how the body handles the medicine and if it shows any early signs of shrinking tumors. This is a first-in-human study, meaning it's the first time this drug is being given to people. The study aims to enroll 210 participants.

Study design
This is a Phase 1a/1b open-label study, meaning both you and your doctors will know which treatment you are receiving. It is designed to evaluate DBC-664 in two parts: dose escalation and dose expansion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will assess safety and tolerability for up to 2 years, and characterize how the body processes the drug for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07705035

DBC-664 in Adult Patients With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Duboce Biopharmaceuticals, Inc.
~210 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:DBC-664

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 2 years
+2 more outcomes measured

Conditions

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

Explore related trials

Endometrial AdenocarcinomaEsophageal AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaLung AdenocarcinomaMalignant Germ Cell TumorOvarian AdenocarcinomaSolid NeoplasmUrothelial Carcinoma

NCT07705035

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Sarah Cannon Research Institute - Denver HealthONE

    Denver, Coloradono site contact published

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennesseeno site contact published

    Recruiting

  • START Midwest

    Grand Rapids, Michiganno site contact published

    Recruiting

  • START New Jersey

    East Brunswick, New Jerseyno site contact published

    Recruiting

  • START New York

    Lake Success, New Yorkno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Lisa Knapp
[email protected]
+1 (650) 442-3367
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety and Tolerability2 years

    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

  • Determine Recommended Dose for Expansion1 year

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

  • Characterize Pharmacokinetics2 years

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