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GI-4000
i
Other names: GI4000, GI-4000, GI 4000, GI 4000 Tarmogen product, inactivated recombinant S. cerevisiae expressing mutant Ras protein
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News alerts, weekly reports and conference planners
Company:
ImmunityBio
Drug class:
RAS inhibitor
Related drugs:
3ms
QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov)
P1/2, N=3, Terminated, ImmunityBio, Inc. | Phase classification: P1b/2 --> P1/2 | N=173 --> 3 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Phase classification • Enrollment change • Trial termination
|
Avastin (bevacizumab) • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • oxaliplatin • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-021 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
3ms
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. (clinicaltrials.gov)
P1/2, N=9, Terminated, ImmunityBio, Inc. | N=79 --> 9 | Trial completion date: Oct 2023 --> Jan 2024 | Active, not recruiting --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial completion date • Trial termination
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
Avastin (bevacizumab) • cisplatin • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
3ms
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed (clinicaltrials.gov)
P1/2, N=4, Terminated, ImmunityBio, Inc. | N=65 --> 4 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial termination
|
Avastin (bevacizumab) • Erbitux (cetuximab) • cisplatin • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Portrazza (necitumumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-021 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
5ms
QUILT-3.039: NANT Pancreatic Cancer Vaccine: Combination Immunotherapy in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (clinicaltrials.gov)
P1/2, N=3, Terminated, ImmunityBio, Inc. | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Trial termination
|
Avastin (bevacizumab) • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • oxaliplatin • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • GI-4000 • Neukoplast (CST-101)
6ms
QUILT-3.070:Pancreatic Cancer Vaccine: Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy (clinicaltrials.gov)
P1/2, N=4, Terminated, ImmunityBio, Inc. | N=173 --> 4 | Unknown status --> Terminated; Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention
Enrollment change • Trial termination
|
Avastin (bevacizumab) • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • oxaliplatin • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • GI-4000 • NK92-CD16-158V • aldoxorubicin (INNO-206)
1year
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. (clinicaltrials.gov)
P1/2, N=79, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Jan 2023 --> Oct 2023 | Trial primary completion date: Dec 2022 --> Sep 2023
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 overexpression • HER-2 amplification • PGR expression
|
Avastin (bevacizumab) • cisplatin • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
over2years
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. (clinicaltrials.gov)
P1/2, N=79, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Jan 2020 --> Jan 2023 | Trial primary completion date: Dec 2019 --> Dec 2022
Trial completion date • Trial primary completion date
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
HER-2 overexpression • HER-2 amplification • PGR expression
|
Avastin (bevacizumab) • cisplatin • 5-fluorouracil • Bavencio (avelumab) • capecitabine • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • ETBX-011 • ETBX-051 • ETBX-061 • GI-4000 • GI-6207 • GI-6301 • NK92-CD16-158V • aldoxorubicin (INNO-206)
over3years
A Phase 2 Randomized Placebo-Controlled Adjuvant Trial of GI-4000, a Recombinant Yeast Expressing Mutated RAS Proteins in Patients with Resected Pancreas Cancer. (PubMed, J Pancreat Cancer)
Subjects (n = 176) received GI-4000 or placebo plus gemcitabine. These results justify continued investigation of GI-4000 in studies stratified for likely responders or in combination with immune check-point inhibitors or other immunomodulators, which may provide optimal reactivation of antitumor immunity. ClinicalTrials.gov Number: NCT00300950.
Clinical • P2 data • Journal
|
IFNG (Interferon, gamma) • FOXP3 (Forkhead Box P3)
|
gemcitabine • GI-4000
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