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DRUG:

GI 4000

i
Other names: GI 4000, GI-4000, GI 4000 Tarmogen product, inactivated recombinant S. cerevisiae expressing mutant Ras protein
Associations
Company:
ImmunityBio
Drug class:
RAS inhibitor
Associations
8ms
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)
2years
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)
3years
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
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IFNG (Interferon, gamma) • FOXP3 (Forkhead Box P3)
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gemcitabine • GI 4000