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.
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.
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.
Sequential
DBC-664
Biological/VaccineDBC-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
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
Characterize Pharmacokinetics
To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration
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