DBC-664 in adults with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, multicenter Phase 1a/1b study evaluating DBC-664 in adults with unresectable, recurrent, or metastatic solid tumors. The trial includes dose-escalation (Phase 1a) to determine safety and recommended dose, followed by dose-expansion (Phase 1b) to explore preliminary anti-tumor activity and pharmacodynamics. Eligibility requires adults with measurable disease per RECIST, while excluding individuals with certain immune deficiencies, organ transplants, active infections, or active autoimmune or pneumonitis conditions. Participation will occur at sites in Denver, Grand Rapids, and St. Louis. Primary goals are safety, tolerability, pharmacokinetics, pharmacodynamics, and early signals of efficacy. The sponsor is Duboce Biopharmaceuticals, Inc., with collaboration at three academic centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sarah Cannon Research Institute - Denver HealthONE
  Denver, Colorado, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• START New Jersey
  East Brunswick, New Jersey, United States Recruiting
• START New York
  Lake Success, New York, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Lisa Knapp
• Email: lknapp@tcglsoleil.com
• Phone: +1 (650) 442-3367

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.