MedPath

GI-4000

Generic Name
GI-4000
Drug Type
Biotech

Overview

A vaccine containing a heat-killed recombinant Saccharomyces cerevisiae yeast transfected with mutated forms of Ras, an oncogene frequently found in solid tumors, with potential immunostimulant and antitumor activity.

Background

A vaccine containing a heat-killed recombinant Saccharomyces cerevisiae yeast transfected with mutated forms of Ras, an oncogene frequently found in solid tumors, with potential immunostimulant and antitumor activity.

Indication

Investigated for use/treatment in pancreatic cancer.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
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
2018/07/02
NCT03574649
Phase 2
Withdrawn
ImmunityBio, Inc.
QUILT-3.088: NANT Pancreatic Cancer Vaccine
2018/06/20
NCT03563144
Phase 2
Withdrawn
ImmunityBio, Inc.
QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine
2018/06/20
NCT03563157
Phase 1
Terminated
ImmunityBio, Inc.
QUILT-3.057: NANT Neoadjuvant Triple- Negative Breast Cancer (TNBC) Vaccine
2018/06/12
NCT03554109
Phase 2
Withdrawn
ImmunityBio, Inc.
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
2017/11/01
NCT03329248
Phase 1
Terminated
ImmunityBio, Inc.
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
2017/06/23
NCT03197571
Phase 1
Withdrawn
ImmunityBio, Inc.
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
2017/06/23
NCT03197584
Phase 1
Withdrawn
ImmunityBio, Inc.
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
2017/06/05
NCT03175666
Phase 1
Withdrawn
ImmunityBio, Inc.
QUILT-3.050: NANT Colorectal Cancer (CRC) Vaccine: Combination Immunotherapy in Subjects With Recurrent or Metastatic CRC
2017/05/30
NCT03169777
Phase 1
Withdrawn
ImmunityBio, Inc.
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
2017/05/30
NCT03169764
Phase 1
Withdrawn
ImmunityBio, Inc.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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