QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers.
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|ClinicalTrials.gov Identifier: NCT03552718|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : April 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Breast Cancer Head and Neck Squamous Cell Carcinoma Melanoma Non Small Cell Lung Cancer Pancreatic Cancer Liver Cancer||Biological: YE-NEO-001||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||QUILT-2.025 NANT Neoepitope Yeast Vaccine (YE-NEO-001): Adjuvant Immunotherapy Using a Personalized Neoepitope Yeast-Based Vaccine To Induce T-Cell Responses In Subjects W/ Previously Treated Cancers.|
|Actual Study Start Date :||August 10, 2018|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 30, 2020|
|Experimental: Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)||
Personalized recombinant yeast-based vaccine engineered to express multiple neoantigen epitopes (neoepitopes) based on an individual subject's tumor molecular profile.
Other Name: YE-NEO-001 Injectable Suspension
- Incidence of treatment-emergent adverse events [ Time Frame: 19 months ]
- Recommended Phase 2 Dose [ Time Frame: 19 months ]
- Recurrence rate [ Time Frame: 19 months ]The appearance of any lesion that is confirmed by biopsy (in subjects with no evidence of disease (NED) at the start of the treatment only)
- Disease-free survival (DFS) [ Time Frame: 24 months ]The time from the date of first YE-NEO-001 treatment to the date of disease recurrence or death (any cause), whichever occurs first (in subjects with NED at the start of treatment only)
- Overall survival (OS) [ Time Frame: 36 months ]The time from the date of first YE-NEO-001 treatment to the date of death (any cause) (in all subjects)
- Progression-free survival (PFS) [ Time Frame: 24 months ]The time from the date of first YE-NEO-001 treatment to the date of disease progression or death (any cause), whichever occurs first (in all subjects)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552718
|Contact: NantBio Clinical Review Team||800-988-6083||clinical.trials@NantKwest.com|
|United States, California|
|Chan Soon-Shiong Institute for Medicine||Recruiting|
|El Segundo, California, United States, 90245|