Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT03552718
Brief Summary:
This is a phase 1 study to evaluate the safety, the Recommended Phase 2 Dose (RP2D), and preliminary efficacy of a personalized neoepitope yeast-based vaccine, YE-NEO-001, in subjects who have completed potentially curative therapy for their solid cancer and who would otherwise be entering a period of surveillance for recurrent disease.
Detailed Description:
This is a phase 1 trial to evaluate the safety, the RP2D, and preliminary efficacy of a personalized neoepitope yeast-based vaccine, YE-NEO-001, in subjects who have completed potentially curative therapy for their type of solid cancer (eg, colorectal cancer, breast cancer, head and neck squamous cell carcinoma, melanoma) and would otherwise be entering a period of surveillance for recurrent disease.
The study will be conducted in two parts: part 1 will involve dose escalation, and part 2 will involve the expansion of the RP2D to further evaluate the safety of YE-NEO-001. In part 2 of the study, dose expansion will occur when the RP2D has been determined. An additional 4 subjects may be enrolled in part 2, for a total of up to 10 subjects at the RP2D.
Study:
NCT03552718
Study Brief:
Protocol Section:
NCT03552718