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DRUG:

guadecitabine (SGI-110)

i
Other names: SGI-110, S-110, SGI110, SGI 110, S110
Associations
Company:
Otsuka
Drug class:
DNMT inhibitor
Associations
9d
Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer (clinicaltrials.gov)
P1, N=55, Active, not recruiting, University of Southern California | Trial completion date: Jul 2026 --> Dec 2026
Trial completion date
|
Imfinzi (durvalumab) • guadecitabine (SGI-110)
29d
HyPeR: Combination Study of Guadecitabine/ASTX727 and Pembrolizumab (clinicaltrials.gov)
P1, N=60, Active, not recruiting, Royal Marsden NHS Foundation Trust | Recruiting --> Active, not recruiting | N=34 --> 60
Enrollment closed • Enrollment change
|
MSI (Microsatellite instability)
|
MSI-H/dMMR
|
Keytruda (pembrolizumab) • Inqovi (decitabine/cedazuridine) • guadecitabine (SGI-110)
1m
Blood Based Biomarkers of DNA Methylation Associated with Platinum Resistance in High Grade Serous Ovarian Cancer. (PubMed, bioRxiv)
Pt resistance in HGSC is associated with epigenetic modifications and hypomethylating agents (HMAs) have been studied as carboplatin resensitizing agents...The Pt-resistant patients were enrolled in NCT02901899 clinical trial testing guadecitabine and the PD-1 inhibitor pembrolizumab...We propose new DMLs associated with Pt-naive versus Pt-resistant HGSC. These findings can lead to new biomarkers for HGSC.
Journal • PD(L)-1 Biomarker • IO biomarker
|
CD4 (CD4 Molecule)
|
Keytruda (pembrolizumab) • carboplatin • guadecitabine (SGI-110)
3ms
Trial completion date
|
Inqovi (decitabine/cedazuridine) • Beleodaq (belinostat) • guadecitabine (SGI-110)
3ms
Effects of the Hypomethylating Agent Guadecitabine on Peripheral Blood Mononuclear Cell Methylomes and Immune Cell Populations in Small-Cell Lung Cancer Patients. (PubMed, bioRxiv)
Guadecitabine, a hypomethylating agent (HMA), has shown promising clinical activity when combined with carboplatin in preclinical models. Methylome changes in peripheral blood mononuclear cell (PBMCs) from small cell lung cancer (SCLC) patients treated with an epigenetic therapy revealed global hypomethylation and altered cancer signaling processes associated with tumor progression, immune response, therapy resistance and significant change in the proportion of immune cells. Integrating blood-based methylation biomarkers into clinical trials of epigenetic therapy and methylomic analysis of PBMCs provides direct monitoring of treatment effects in cancer patients, which may improve patient selection and enable real-time response assessment in patients receiving hypomethylating agents.
Journal
|
NGFR (Nerve Growth Factor Receptor)
|
carboplatin • guadecitabine (SGI-110)
4ms
NCI-2016-01233: Guadecitabine and Atezolizumab in Treating Patients With Advanced Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia That Is Refractory or Relapsed (clinicaltrials.gov)
P1/2, N=33, Active, not recruiting, University of Southern California | Trial completion date: Dec 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2026
Trial completion date • Trial primary completion date • Checkpoint inhibition
|
Tecentriq (atezolizumab) • guadecitabine (SGI-110)
6ms
Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer (clinicaltrials.gov)
P1, N=55, Active, not recruiting, University of Southern California | Trial completion date: Dec 2025 --> Jul 2026
Trial completion date
|
Imfinzi (durvalumab) • guadecitabine (SGI-110)
10ms
Epigenetic Modulation and Bone Metastasis: Evolving Therapeutic Strategies. (PubMed, Pharmaceuticals (Basel))
DNA methyltransferase inhibitors (e.g., decitabine, guadecitabine) have shown promise in attenuating osteoclast differentiation, while histone deacetylase inhibitors display context-dependent effects on tumor progression and bone remodeling...Together, these advances position epigenetic modulation as a promising axis in precision oncology aimed at interrupting the pathological crosstalk between tumor cells and the bone microenvironment. This review synthesizes current mechanistic understanding, evaluates the therapeutic landscape, and outlines the translational challenges ahead in leveraging epigenetic science to prevent and treat bone metastases.
Review • Journal • IO biomarker
|
SMARCA4 (SWI/SNF related, matrix associated, actin dependent regulator of chromatin, subfamily A, member 4) • MIR34A (MicroRNA 34a-5p) • RASSF1 (Ras Association Domain Family Member 1) • NORAD (Non-Coding RNA Activated By DNA Damage)
|
guadecitabine (SGI-110)
10ms
Pembrolizumab (Immunotherapy Drug) in Combination With Guadecitabine and Mocetinostat (Epigenetic Drugs) for Patients With Advanced Lung Cancer. (clinicaltrials.gov)
P1, N=28, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2025 --> Jul 2026
Trial completion date • Trial primary completion date
|
Keytruda (pembrolizumab) • mocetinostat (MGCD0103) • guadecitabine (SGI-110)
11ms
NCI-2016-01233: Guadecitabine and Atezolizumab in Treating Patients With Advanced Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia That Is Refractory or Relapsed (clinicaltrials.gov)
P1/2, N=33, Active, not recruiting, University of Southern California | Trial completion date: Nov 2025 --> Dec 2026 | Trial primary completion date: Nov 2024 --> Dec 2025
Trial completion date • Trial primary completion date • Checkpoint inhibition
|
Tecentriq (atezolizumab) • guadecitabine (SGI-110)
1year
Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov)
P1/2, N=12, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | N=75 --> 12
Trial completion • Enrollment change • IO biomarker
|
PD-L1 (Programmed death ligand 1) • CTAG1B (Cancer/testis antigen 1B)
|
Tecentriq (atezolizumab) • Hiltonol (poly-ICLC) • guadecitabine (SGI-110) • rasdegafusp alfa (CDX-1401)
over1year
Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer (clinicaltrials.gov)
P1, N=55, Active, not recruiting, University of Southern California | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Mar 2021 --> Apr 2024
Trial completion date • Trial primary completion date
|
Imfinzi (durvalumab) • guadecitabine (SGI-110)