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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OBI-821 | Other / unclassified | 100 ug | — |
| Subject | OBI-833 | Vaccine | 30 ug | — |
| Background | Erlotinib | Small molecule | 150 mg | — |