Phase IbII Study of HMBD-001 With Cetuximab, With or Without Docetaxel, for Advanced Squamous Cell Cancers

What this Trial Is About

Researchers are evaluating HMBD-001, an anti-HER3 antibody, in combination with cetuximab with or without docetaxel for people with advanced squamous cell cancers. This Phase IbII, open-label, multi-center study focuses on various types of advanced or metastatic squamous cell carcinomas, including lung, head and neck, esophageal, cervical, cutaneous, and nasopharyngeal cancers. The study aims to assess the safety and effectiveness of these treatments in participants who have limited standard care options. Participants receive HMBD-001 intravenously once a week alongside cetuximab weekly, with or without docetaxel administered every three weeks. There are three treatment arms one with HMBD-001 plus docetaxel, one with HMBD-001 plus docetaxel and cetuximab both closed to recruitment, and one with HMBD-001 plus cetuximab. The trial evaluates different combinations to understand their effects on advanced squamous cell cancers. During the study, participants are monitored for adverse events and dose-limiting toxicities. Researchers track progression-free survival up to six months and measure tumor response using established criteria. Blood samples are collected to study the drugs behavior in the body and immune response. The study includes repeated treatment cycles and safety follow-up, with assessments continuing up to 48 months. Participants undergo tumor biopsies and organ function tests to ensure safety and gather comprehensive data.

A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers