Adults 18 to 100, any sex, with Neoplasms or Malignant Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Brachyury-Specific T-cell ResponsesPrimary· Baseline (pre-vaccination) and approximately day 84 (after 6 vaccinations)
A fluorescense activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.
CD107a + CD4 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
1
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
4
80 YU (Dose Level 4)
1
IFN gamma + CD4 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
1
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
3
80 YU (Dose Level 4)
2
IL2 + CD4 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
3
80 YU (Dose Level 4)
3
TNF alpha + CD4 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
1
40 YU (Dose Level 3)
6
80 YU (Dose Level 4)
2
CD107a + CD8 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
3
80 YU (Dose Level 4)
4
IFN gamma + CD8 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
3
80 YU (Dose Level 4)
2
IL2 + CD8 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
0
80 YU (Dose Level 4)
1
TNF alpha + CD8 T-cell response
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
2
80 YU (Dose Level 4)
3
Count of Participants With Adverse Events of Escalating Doses of Yeast Brachyury ( GI- 6301) VaccinePrimary· 4 years and 25 days
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one o
Group
Value
95% CI
4 YU (Dose Level 1)
4
16 YU (Dose Level 2)
3
40 YU (Dose Level 3)
16
80 YU (Dose Level 4)
10
Number of Participants With a Clinical Benefit Assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)Secondary· 3 and 5 months restaging
Clinical benefit is defined as partial response (PR) or stable disease (SD) and was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Partial response is ≥30% decrease in the sum of greatest diameters/no new lesions. Progressive disease is ≥20% increase in the sum of greatest diameters/new lesions. Stable disease does not meet criteria for complete response (disappearance of all lesions; no new lesions), partial response, or progressive disease.
Stable disease at 3 months
Group
Value
95% CI
4 YU (Dose Level 1)
3
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
8
80 YU (Dose Level 4)
6
Stable disease at 5 months
Group
Value
95% CI
4 YU (Dose Level 1)
2
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
4
80 YU (Dose Level 4)
3
Partial response at 3 months
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
0
80 YU (Dose Level 4)
0
Partial response at 5 months
Group
Value
95% CI
4 YU (Dose Level 1)
0
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
1
80 YU (Dose Level 4)
0
Progressive disease at 3 months
Group
Value
95% CI
4 YU (Dose Level 1)
1
16 YU (Dose Level 2)
3
40 YU (Dose Level 3)
8
80 YU (Dose Level 4)
5
Progressive disease at 5 months
Group
Value
95% CI
4 YU (Dose Level 1)
1
16 YU (Dose Level 2)
0
40 YU (Dose Level 3)
3
80 YU (Dose Level 4)
0
Changes in Immune Cell Subsets in Peripheral Blood Mononuclear Cells (PBMC)Secondary· Pre (Baseline) and Day 85 after 6 vaccinations
Blood samples will be collected via apheresis and analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC), Tregs, CD4 central memory (CD4 CM), CD4 effector memory (CD4 EM), CD4 terminal effector memory (CD4 EMRA), CD4 naïve, CD8 CM, CD8 EM, CD8 EMRA, and CD8 naïve cells. Significance of changes in immune cells was determined by p value (Wilcoxon test) and the median and interq
Median CD4 Pre
Group
Value
95% CI
4 YU (Dose Level 1)
37.70
24.11 – 46.36
16 YU (Dose Level 2)
43.57
40.26 – 46.87
40 YU (Dose Level 3)
29.30
24.65 – 39.77
80 YU (Dose Level 4)
33.58
26.84 – 39.92
Median CD4 d85
Group
Value
95% CI
4 YU (Dose Level 1)
38.61
24.44 – 47.73
16 YU (Dose Level 2)
33.44
33.37 – 33.52
40 YU (Dose Level 3)
34.29
25.56 – 37.44
80 YU (Dose Level 4)
27.99
25.85 – 39.38
Median CD8 Pre
Group
Value
95% CI
4 YU (Dose Level 1)
15.87
8.26 – 16.86
16 YU (Dose Level 2)
14.77
3.49 – 26.04
40 YU (Dose Level 3)
15.96
10.76 – 19.48
80 YU (Dose Level 4)
13.76
10.31 – 19.77
Median CD8 d85
Group
Value
95% CI
4 YU (Dose Level 1)
15.67
9.102 – 16.57
16 YU (Dose Level 2)
13.63
4.123 – 23.14
40 YU (Dose Level 3)
15.42
10.96 – 22.44
80 YU (Dose Level 4)
16.02
10.57 – 25.5
Median B cells Pre
Group
Value
95% CI
4 YU (Dose Level 1)
7.05
6.19 – 10.07
16 YU (Dose Level 2)
11.02
9.92 – 12.11
40 YU (Dose Level 3)
8.97
3.54 – 12.13
80 YU (Dose Level 4)
7.82
3.13 – 12.07
Median B cells d85
Group
Value
95% CI
4 YU (Dose Level 1)
6.93
6.16 – 10.58
16 YU (Dose Level 2)
9.78
7.95 – 11.62
40 YU (Dose Level 3)
9.10
5.07 – 12.17
80 YU (Dose Level 4)
8.77
3.78 – 10.72
Median Natural Killer (NK) Pre
Group
Value
95% CI
4 YU (Dose Level 1)
5.21
4.14 – 6.94
16 YU (Dose Level 2)
6.57
3.27 – 9.87
40 YU (Dose Level 3)
5.72
3.13 – 8.51
80 YU (Dose Level 4)
5.89
4.59 – 9.14
Median Natural Killer (NK) d85
Group
Value
95% CI
4 YU (Dose Level 1)
5.72
4.03 – 7.39
16 YU (Dose Level 2)
8.41
5.50 – 11.31
40 YU (Dose Level 3)
4.22
3.97 – 10.07
80 YU (Dose Level 4)
9.14
5.95 – 11.4
Changes in Serum Levels of CytokinesSecondary· Pre (Baseline) and Day 85 after 6 vaccinations
Blood samples were collected and changes in serum levels of cytokines interferon gamma (IFNg), Interleukin 10 (IL-10), Interleukin 12 (IL-12)p70, Interleukin 1b (IL-1b), Interleukin 2 (IL-2), Interleukin 6 (IL-6), Interleukin 8 (IL-8), and tumor necrosis factor (TNF) were assessed by the multiplexed mesoscale assay. Significance of changes in serum levels of cytokines was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Median IFNg Pre
Group
Value
95% CI
4 YU (Dose Level 1)
3.63
2.47 – 6.12
16 YU (Dose Level 2)
3.56
2.99 – 4.13
40 YU (Dose Level 3)
2.805
1.97 – 3.6
80 YU (Dose Level 4)
4.47
4.05 – 7.48
Median IFNg d85
Group
Value
95% CI
4 YU (Dose Level 1)
2.64
2.17 – 3.17
16 YU (Dose Level 2)
2.83
2.62 – 3.04
40 YU (Dose Level 3)
2.84
1.76 – 4.71
80 YU (Dose Level 4)
4.9
2.91 – 6.81
Median IL-10 Pre
Group
Value
95% CI
4 YU (Dose Level 1)
0.24
0.17 – 0.54
16 YU (Dose Level 2)
0.215
0.2 – 0.23
40 YU (Dose Level 3)
0.21
0.17 – 0.28
80 YU (Dose Level 4)
0.4
0.31 – 0.47
Median IL-10 d85
Group
Value
95% CI
4 YU (Dose Level 1)
0.26
0.23 – 0.39
16 YU (Dose Level 2)
0.285
0.28 – 0.29
40 YU (Dose Level 3)
0.24
0.18 – 0.31
80 YU (Dose Level 4)
0.4
0.26 – 0.52
Median IL-12p70 Pre
Group
Value
95% CI
4 YU (Dose Level 1)
0.2
0.2 – 0.22
16 YU (Dose Level 2)
0.22
0.2 – 0.24
40 YU (Dose Level 3)
0.2
0.2 – 0.2
80 YU (Dose Level 4)
0.2
0.2 – 0.37
Median IL-12p70 d85
Group
Value
95% CI
4 YU (Dose Level 1)
0.2
0.2 – 0.28
16 YU (Dose Level 2)
0.2
0.2 – 0.2
40 YU (Dose Level 3)
0.2
0.2 – 0.2
80 YU (Dose Level 4)
0.2
0.2 – 0.26
Median IL-1b Pre
Group
Value
95% CI
4 YU (Dose Level 1)
0.24
0.24 – 1.15
16 YU (Dose Level 2)
0.24
0.24 – 0.24
40 YU (Dose Level 3)
0.24
0.24 – 0.24
80 YU (Dose Level 4)
0.24
0.24 – 2.52
Median IL-1b d85
Group
Value
95% CI
4 YU (Dose Level 1)
0.24
0.24 – 0.25
16 YU (Dose Level 2)
0.24
0.24 – 0.24
40 YU (Dose Level 3)
0.24
0.24 – 0.24
80 YU (Dose Level 4)
0.24
0.24 – 0.89
Changes in Soluble Cluster of Differentiation 27 (sCD27)Secondary· Pre (Baseline) and Day 85 after 6 vaccinations
Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27 was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Median sCD27 Pre
Group
Value
95% CI
4 YU (Dose Level 1)
99.07
91.13 – 131
16 YU (Dose Level 2)
98.63
87.12 – 110.1
40 YU (Dose Level 3)
97.47
85.15 – 110.9
80 YU (Dose Level 4)
128.4
123.9 – 145.6
Median sCD27 d85
Group
Value
95% CI
4 YU (Dose Level 1)
97.17
92.07 – 1112
16 YU (Dose Level 2)
92.07
83.3 – 100.8
40 YU (Dose Level 3)
101.7
98.85 – 105.1
80 YU (Dose Level 4)
133.1
129.7 – 155.8
Median Ratio of Soluble Cluster of Differentiation 27:40L (sCD27:sCD40L)Secondary· Pre (Baseline) and Day 85 after 6 vaccinations
Blood samples were collected and changes in serum levels of the ratio of soluble sCD27:sCD40L was assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD27:sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Median sCD27:sCD40L Pre
Group
Value
95% CI
4 YU (Dose Level 1)
5.982
5.71 – 11.67
16 YU (Dose Level 2)
9.57
7.88 – 11.26
40 YU (Dose Level 3)
9.571
7.67 – 19.89
80 YU (Dose Level 4)
8.57
6.93 – 10.62
Median sCD27:sCD40L d85
Group
Value
95% CI
4 YU (Dose Level 1)
6.428
4.79 – 9.43
16 YU (Dose Level 2)
8.294
7.29 – 9.29
40 YU (Dose Level 3)
10.47
6.63 – 19.38
80 YU (Dose Level 4)
8.257
6.96 – 8.91
Changes in Soluble Cluster of Differentiation 40L (sCD40L)Secondary· Pre (Baseline) and Day 85 after 6 vaccinations
Blood samples were collected and changes in serum levels of soluble sCD27 were assessed by enzyme-linked immunosorbent assay (ELISA). Significance of changes in soluble sCD40L was determined by p value (Wilcoxon test) and the median and interquartile range of data.
Median sCD40L Pre
Group
Value
95% CI
4 YU (Dose Level 1)
15.3
11.39 – 17.99
16 YU (Dose Level 2)
10.24
9.78 – 11.06
40 YU (Dose Level 3)
9.648
5.27 – 13.99
80 YU (Dose Level 4)
14.72
13.67 – 18.74
Median sCD40L d85
Group
Value
95% CI
4 YU (Dose Level 1)
15.23
11.96 – 19.42
16 YU (Dose Level 2)
11.14
10.84 – 11.43
40 YU (Dose Level 3)
9.854
5.86 – 14.52
80 YU (Dose Level 4)
18.57
16.09 – 19.51
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 years and 25 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
4 YU (Dose Level 1)
Serious: 0/4 (0%)
Deaths: 0/4
16 YU (Dose Level 2)
Serious: 0/3 (0%)
Deaths: 0/3
40 YU (Dose Level 3)
Serious: 5/16 (31%)
Deaths: 0/16
80 YU (Dose Level 4)
Serious: 6/11 (55%)
Deaths: 0/11
Serious adverse events (19 terms)
Reaction
System
4 YU (Dose Level 1)
16 YU (Dose Level 2)
40 YU (Dose Level 3)
80 YU (Dose Level 4)
Small intestinal obstruction
Gastrointestinal disorders
—
—
—
—
Abdominal pain
Gastrointestinal disorders
—
—
—
—
Aortic valve disease
Cardiac disorders
—
—
—
—
Atrial fibrillation
Cardiac disorders
—
—
—
—
Chest wall pain
Musculoskeletal and connective tissue disorders
—
—
—
—
Hyperglycemia
Metabolism and nutrition disorders
—
—
—
—
Urinary tract obstruction
Renal and urinary disorders
—
—
—
—
Wound infection
Infections and infestations
—
—
—
—
Atelectasis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Bone infection
Infections and infestations
—
—
—
—
Cholecystitis
Hepatobiliary disorders
—
—
—
—
Eye infection
Eye disorders
—
—
—
—
Fatigue
General disorders
—
—
—
—
Lung infection
Infections and infestations
—
—
—
—
Respiratory, thoracic and mediastinal disorders - Other, lung obstruction
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Soft tissue infection
Infections and infestations
—
—
—
—
Upper respiratory infection
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Urinary tract infection
Renal and urinary disorders
—
—
—
—
Wheezing
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Other adverse events (125 terms — click to expand)
Background:
\- Cancer vaccines are being developed to help teach the body's immune system to attack and destroy cancer cells. A new vaccine being tested targets Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas.
Objectives:
\- To test the safety and effectiveness of a cancer vaccine that targets Brachyury protein in tumor cells.
Eligibility:
* Individuals at least 18 years of age who have advanced cancers that have not responded or are no longer responding to standard treatments.
* Because the vaccine is made with yeast, people with yeast allergies will not be eligible.
Design:
* Participants will be screened with a medical history and physical exam. Imaging studies will be used to examine the cancer. Heart and thyroid function tests will be conducted. Blood and urine samples will also be collected.
* Participants will receive vaccine injections every 2 weeks, for a total of seven visits. After seven visits, if the cancer has shrunk or stopped growing, participants will continue to have the vaccine about once a month.
* Treatment will be monitored with frequent blood tests and imaging studies. Other tests will be given as directed by the study doctors. Some participants will have apheresis to collect additional blood cells for study.
* Participants will continue to receive the vaccine as long the tumor does not start growing again and there are no serious side effects....
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07438782 — First Time in Human (FTIH) Study to Investigate the Safety and Preliminary Activity of GSK5533524 Alone or in Combinatio
· Phase 1
· recruiting
NCT07382817 — Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms
· Phase 1
· recruiting
NCT07277270 — A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tum
· Phase 1
· recruiting
NCT07213609 — A Study to Investigate the Safety and Preliminary Efficacy of GSK5460025 Alone or in Combination With Other Anti-cancer
· Phase 1, PHASE2
· recruiting
Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem
· Phase 1, PHASE2
· recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After
· Phase 1
· not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 29 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01519817.