A Phase 1 interventional study of DBC-664 in Malignant Germ Cell Tumor, Lung Adenocarcinoma and Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, sponsored by Duboce Biopharmaceuticals, Inc.. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Duboce Biopharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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.
Exclusion Criteria:
Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen.
Biological: DBC-664
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
DBC-664 will be administered intravenously.
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
Time frame: 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
Time frame: 1 year
Characterize Pharmacokinetics
To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration
Time frame: 2 years
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