A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of DBC-664 in Adult Patients With Locally Advanced or Metastatic Solid Tumors
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.