DBC-664: DBC-664 will be administered intravenously.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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:
* 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.
Primary outcome measure(s)
Safety and Tolerability — 2 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 Expansion — 1 year To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE\[s\]) of DBC-664
Characterize Pharmacokinetics — 2 years To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration
Trial sites (5)
Facility
City
Region
Status
Sarah Cannon Research Institute - Denver HealthONE
Denver
Colorado
Recruiting
START Midwest
Grand Rapids
Michigan
Recruiting
START New Jersey
East Brunswick
New Jersey
Recruiting
START New York
Lake Success
New York
Recruiting
SCRI Oncology Partners
Nashville
Tennessee
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.