DBC-664 in Adult Patients With Solid Tumors

NCT07705035 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DBC-664-ONC-101
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 3

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; Ovarian Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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

  2 years

• 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

  1 year

• Characterize Pharmacokinetics

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

  2 years

Study Arms (2)

Part 1 (Dose Escalation)

EXPERIMENTAL

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

Biological: DBC-664

Part 2 (Dose Expansion)

EXPERIMENTAL

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

DBC-664 BIOLOGICAL

DBC-664 will be administered intravenously.

Part 1 (Dose Escalation); Part 2 (Dose Expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duboce Biopharmaceuticals, Inc.: lead

Study Sites (3)

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

MeSH Terms

Conditions

Adenocarcinoma of Lung; Adenocarcinoma; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Central Study Contacts

Lisa Knapp

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 15, 2026
• Study Start: June 17, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

US (3)