drugset / Trial / NCT05442060

To Evaluate OBI-833/OBI-821 in Combination With First-Line Erlotinib in Patients With EGFR-Mutated, Globo H-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT05442060

Phase 2 Recruiting 60 enrolled OBI Pharma, Inc
RandomizedParallel-groupOpen-labelPrevention

Summary

This study is a randomized, active control, open-label, phase 2 trial. Erlotinib-treated NSCLC patients will be screened for Globo H, and only Globo H+ (H score ≥ 100) subjects are eligible for the study. Eligible subjects who have been treated with 3±1 months of first-line erlotinib and have achieved stable disease (SD) or partial response (PR) status will be randomized in the ratio of 1:1 to receive erlotinib alone or erlotinib plus OBI-833/OBI-821 therapy.

Timeline

Start
2022-07-27
Primary completion
2025-12-31
Completion
2026-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject OBI-821 Other / unclassified 100 ug
Subject OBI-833 Vaccine 30 ug
Background Erlotinib Small molecule 150 mg