Phase 12 Study of IDP-001 Given by IV Infusion for Advanced or Metastatic Squamous Cell Lung Cancer and Other Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early antitumor effects of IDP-001 in adults with advanced or metastatic squamous and non-squamous non-small cell lung cancer and other squamous cell solid tumors such as head and neck, esophageal, cervical, and cutaneous cancers. This is a Phase 12 open-label study focused on these advanced cancers where standard treatments are limited or no longer effective. Participants will receive IDP-001 as an intravenous infusion. The study includes two parts Phase 1 Part 1 involves dose escalation to determine safety and tolerability over 3-week cycles, while Phase 1 Part 2 focuses on indication selection, evaluating response rates and duration over approximately 6 months. The study is non-randomized and open-label, with all participants receiving the investigational drug. During the study, participants will undergo tumor biopsies and regular assessments including imaging to measure tumor response using RECIST criteria. Safety monitoring includes tracking adverse events and dose modifications. Pharmacokinetic measurements and antibody levels against the drug will be collected. The study duration varies but includes up to 6 months of treatment evaluation and longer-term follow-up for survival outcomes up to 18 months.

A Study of IDP-001 in Advanced or Metastatic Solid Tumors