10 withdrawn, 8 terminated, 2 completed. 20 Phase 2, 14 Phase 1.
By phase and status
Follow GI-4000: new trials by email Literature Review of GI-4000 trials Research Report on GI-4000
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine Aldoxorubicin Hydrochloride, ALT-803, ETBX-011 - Colorectal Cancer Metastatic, mCRC | Phase 1 / Phase 2 | Terminated | 2 | 2018-09-28 | 2024-12-11 |
QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine Leucovorin, 5-Fluorouracil, Aldoxorubicin HCl - Triple Negative Breast Cancer (TNBC) | Phase 2 | Withdrawn | | 2018-09-01 | 2025-02-21 |
QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC avelumab, bevacizumab, capecitabine - Colorectal Cancer | Phase 1 / Phase 2 | Withdrawn | | 2018-08-01 | 2025-02-21 |
QUILT-3.088: NANT Pancreatic Cancer Vaccine Gemcitabine, Nab-paclitaxel, Aldoxorubicin HCl - Metastatic Pancreatic Cancer | Phase 2 | Withdrawn | | 2018-08-01 | 2025-02-21 |
QUILT-3.080: NANT Pancreatic Cancer Vaccine Aldoxorubicin HCl, ALT-803, ETBX-011 - Pancreatic Cancer | Phase 1 / Phase 2 | Terminated | 3 | 2018-07-17 | 2024-08-27 |
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Nab-paclitaxel, Cisplatin, 5Fluorouracil - Non Small Cell Lung Cancer | Phase 2 | Withdrawn | | 2018-06-01 | 2025-02-21 |
QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine ETBX-011, GI-4000, haNK for infusion - Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma Recurrent | Phase 1 / Phase 2 | Withdrawn | | 2018-05-25 | 2021-03-18 |
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. Aldoxorubicin HCl, N-803, ETBX-011 - Triple Negative Breast Cancer | Phase 1 / Phase 2 | Terminated | 9 | 2018-03-19 | 2024-08-09 |
QUILT-3.044: NANT Non-small Cell Lung Cancer (NSCLC) Vaccine: Combination Immunotherapy in Subjects With NSCLC Who Have Progressed After Treatment With PD-1/PD-L1 Inhibitors avelumab, Bevacizumab, Capecitabine - Non-small Cell Lung Cancer | Phase 1 / Phase 2 | Withdrawn | | 2018-02-01 | 2025-02-21 |
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed Aldoxorubicin HCl, ETBX-011, ETBX-021 - Squamous Cell Carcinoma | Phase 1 / Phase 2 | Terminated | 4 | 2018-01-09 | 2024-08-05 |
QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Aldoxorubicin HCl, ALT-803, ETBX-011 - Pancreatic Cancer | Phase 1 / Phase 2 | Terminated | 4 | 2017-12-28 | 2024-05-22 |
QUILT-3.049: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Combination Immunotherapy in Subjects With TNBC Who Have Progressed on or After Anthracycline-based Chemotherapy avelumab, bevacizumab, capecitabine - Triple Negative Breast Cancer | Phase 1 / Phase 2 | Withdrawn | | 2017-12-01 | 2025-02-21 |
QUILT-3.047: NANT Head and Neck Squamous Cell Carcinoma (HNSCC) Vaccine: Combination Immunotherapy in Subjects With HNSCC Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy Avelumab, Bevacizumab, Capecitabine - Head and Neck Squamous Cell Carcinoma | Phase 1 / Phase 2 | Withdrawn | | 2017-12-01 | 2025-02-24 |
QUILT-3.051: NANT Ovarian Cancer Vaccine: Combination Immunotherapy in Subjects With Epithelial Ovarian Cancer Who Have Progressed on or After Standard-of-care (SoC) Therapy Avelumab, Bevacizumab, Capecitabine - Ovarian Cancer | Phase 1 / Phase 2 | Withdrawn | | 2017-12-01 | 2025-02-21 |
QUILT-3.048: NANT Urothelial Cancer Vaccine: Combination Immunotherapy in Subjects With Urothelial Cancer Who Have Progressed on or After Chemotherapy and PD-1/PD-L1 Therapy avelumab, bevacizumab, capecitabine - Urothelial Carcinoma | Phase 1 / Phase 2 | Withdrawn | | 2017-12-01 | 2025-02-21 |
QUILT-3.060: NANT Pancreatic Cancer Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy ALT-803, ETBX-011, GI-4000 - Pancreatic Cancer | Phase 1 / Phase 2 | Terminated | 6 | 2017-11-06 | 2024-12-12 |
QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy Cyclophosphamide, Oxaliplatin, Capecitabine - Pancreatic Cancer | Phase 1 / Phase 2 | Terminated | 3 | 2017-08-11 | 2024-06-11 |
A Pilot Trial of GI-4000 Plus Bevacizumab and Either FOLFOX or FOLFIRI chemotherapy and GI-4000, GI-4000 - Colon Cancer | Phase 2 | Terminated | 11 | 2010-10-01 | 2016-08-15 |
A Pilot Phase 2 Trial of the Immunogenicity, and Safety of GI-4000; an Inactivated Recombinant S. Cerevisiae Expressing Mutant Ras Protein, as Consolidation Therapy Following Curative Treatment for Stage I-III Non-Small Cell Lung Cancer (NSCLC) With Tumor Sequence Confirmation of K-ras Mutation GI-4000 - NSCLC | Phase 2 | Completed | 24 | 2008-04-01 | 2014-01-29 |
Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer GI-4000, Gemcitabine - Pancreas Cancer | Phase 2 | Completed | 176 | 2006-01-01 | 2015-04-06 |
Conditions studied
Pancreatic Neoplasms (6) · Triple Negative Breast Neoplasms (3) · Carcinoma, Non-Small-Cell Lung (2) · Colorectal Neoplasms (2) · Carcinoma, Squamous Cell (1) · Carcinoma, Transitional Cell (1) · Colonic Neoplasms (1) · Neoplasm Metastasis (1) · Ovarian Neoplasms (1) · Squamous Cell Carcinoma of Head and Neck (1)
Sponsors
ImmunityBio, Inc. (17) · GlobeImmune (2) · Georgetown University (1)
Countries
United States (14) · India (1)
Top investigators
Jamie Chaft, MD (1) · John L Marshall, MD (1)
Results publications
PMID 33786412