AzTrials
AzTrials

Colorectal CancerPhase 1NCT03552718

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.

A Phase 1 study testing YE-NEO-001 in people with Colorectal Cancer and Breast Cancer, run by NantBioScience, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
YE-NEO-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
10 Aug 2018to 18 Mar 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-treatment Phase: Tissue Procurement and Development of Vaccine
  • Age ≥ 18 years old.
  • Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
  • Histologically-confirmed cancer amenable to treatment with curative intent as part of SoC. Must be willing to provide a tumor tissue sample (either a tumor biopsy specimen or tissue from resected tumor not used for diagnostic purposes) and a blood sample for tumor molecular profiling.
  • Solid cancers include any of the following surgically resectable cancers: colorectal cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, breast cancer (either hormone receptor positive, HER2-positive or negative, or triple-negative breast cancer), pancreatic cancer, liver cancer, and melanoma. Curative therapy, whether surgery, radiation therapy, or adjuvant chemotherapy, must be completed per National Comprehensive Cancer Network (NCCN) guidelines.
  • Must be willing to agree to initiation of development of personalized YE-NEO-001 vaccine.
Show all 15Show fewer
  • Treatment Phase:
  • No evidence of disease (NED) at first assessment post multi-modality therapy (ie, surgery and/or radiation therapy and/or chemotherapy). Subjects treated with definitive radiation therapy are considered NED if they have no evidence of cancer growth on the first and second surveillance CT scans. Subjects who have disease recurrence prior to the start of the vaccination process are also eligible if no satisfactory alternative treatment options are available or if subject has refused all other available therapies.
  • Must have received < 6 months of SoC therapy.
  • Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.
  • ECOG performance status of 0 to 2.
  • Must be willing to provide blood samples prior to the start of treatment on this study for exploratory analyses.
  • If cancer recurs while on treatment on this study, must be willing to provide a tumor biopsy specimen for exploratory analyses, if considered safe by the Investigator.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Agreement to practice effective contraception for female subjects with child-bearing potential and non-sterile males. Female subjects of child-bearing potential must agree to use effective contraception for up to 1 year after completion of therapy, and non-sterile male subjects must agree to use a condom for up to 4 months after treatment. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, IUDs, and abstinence.

Who cannot join

  • Pre-treatment Phase: Tissue Procurement and Development of Vaccine
  • 1. Unable or unwilling to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Treatment Phase:
  • Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
  • Active autoimmune disease requiring systemic immunosuppressive treatment within 4 weeks prior to enrollment on this study (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, autoimmune disease associated with lymphoma, ankylosing spondylitis, scleroderma, multiple sclerosis). A history of inactive autoimmune disease or autoimmune disease not requiring systemic immunosuppressive therapy within 4 weeks prior to study enrollment is allowed.
  • History of organ transplant requiring immunosuppression.
Show all 24Show fewer
  • History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
  • Inadequate organ function, evidenced by the following laboratory results:
  • ANC < 1,000 cells/mm^3.
  • Platelet count < 75,000 cells/mm^3.
  • Uncorrectable grade 3 anemia (hemoglobin < 8 g/dL).
  • Total bilirubin > ULN (unless the subject has documented Gilbert's syndrome).
  • AST (SGOT) or ALT (SGPT) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
  • Alkaline phosphatase levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or > 10 × ULN in subjects with bone metastases).
  • Serum creatinine > 2.0 mg/dL or 177 μmol/L.
  • Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia requiring medication. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
  • Positive results of screening test for HIV.
  • Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
  • Known hypersensitivity to any component of the study medication(s).
  • Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with the study treatment. Anti-androgen and anti-estrogen medications are allowed.
  • Participation in an investigational drug study or history of receiving any investigational treatment within 30 days prior to initiation of treatment on this study, except for testosterone-lowering therapy in men with prostate cancer.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chan Soon-Shiong Institute for Medicine

    El Segundo, California, 90245

Other trials in United States

About this study

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.

Read the 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.

Being tested
YE-NEO-001
Keywords
solid tumors
Medical subject headings
Colorectal Neoplasms, Breast Neoplasms, Squamous Cell Carcinoma of Head and Neck, Melanoma, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YE-NEO-001Biological

    Also called YE-NEO-001 Injectable Suspension

    Personalized recombinant yeast-based vaccine engineered to express multiple neoantigen epitopes (neoepitopes) based on an individual subject's tumor molecular profile.

Study groups in NCT03552718
Study groupRoleWhat they receive
Experimental: NANT Neoepitope Yeast Vaccine (YE-NEO-001)ExperimentalNot described
Receives: Biological: YE-NEO-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events

    Measured: 19 months

  2. Recommended Phase 2 Dose

    Measured: 19 months

Secondary outcomes (4)

  1. Recurrence rate

    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)

    Measured: 19 months

  2. Disease-free survival (DFS)

    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)

    Measured: 24 months

  3. Overall survival (OS)

    The time from the date of first YE-NEO-001 treatment to the date of death (any cause) (in all subjects)

    Measured: 36 months

  4. Progression-free survival (PFS)

    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)

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study start10 Aug 2018
  3. Primary completion18 Mar 2025
  4. Study completion18 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552718
Sponsor's protocol ID
QUILT-2.025
Status last verified
May 2026
First submitted
25 May 2018
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YE-NEO-001 in people with Colorectal Cancer and Breast Cancer, run by NantBioScience, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (time frame: 19 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552718.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in