^
    10ms
    A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=70, Recruiting, CG Pharmaceuticals, Inc | Phase classification: P1b/2 --> P1/2
    Phase classification • Metastases
    |
    5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • ivaltinostat IV (CG-745)
    11ms
    Results of the safety and tolerability of ivaltinostat plus capecitabine in the phase 1b portion of a phase 1b/2, dose-escalation, randomized, multi-center study in the maintenance (maint) setting in patients with metastatic pancreatic adenocarcinoma (mPDAC). (ASCO-GI 2024)
    Clinical Trial Registration Number NCT05249101 Sponsored by CG Pharma Background: The standard of care for patient (pts) with advanced or mPDAC typically consists of mFOLFIRINOX or gemcitabine/nab-paclitaxel used in the front-line setting until disease progression (prog) or toxicity... Combination therapy of ival with cape has been well tolerated and the safety and PK/PD data support a RP2D of ival of 250 mg/m2. Clinical trial information: NCT05249101.
    Clinical • P1/2 data • BRCA Biomarker • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    gemcitabine • 5-fluorouracil • capecitabine • albumin-bound paclitaxel • irinotecan • ivaltinostat IV (CG-745)
    1year
    Multiple Ascending Dose Study of CG200745 'Ivaltinostat' Oral Capsule (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Machaon Biotherapeutics, Inc. | Not yet recruiting --> Active, not recruiting
    Enrollment closed
    |
    ivaltinostat IV (CG-745)
    1year
    A Study of Ivaltinostat Plus Capecitabine or Capecitabine in Metastatic Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1b/2, N=70, Recruiting, CG Pharmaceuticals, Inc | Trial primary completion date: Sep 2023 --> Feb 2025
    Trial primary completion date • Metastases
    |
    5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • ivaltinostat IV (CG-745)
    over2years
    A Phase I/II Study of Ivaltinostat Combined with Gemcitabine and Erlotinib in Patients with Untreated Locally Advanced or Metastatic Pancreatic Adenocarcinoma. (PubMed, Int J Cancer)
    Correlative studies showed that mutation burden detected by cfDNA and specific blood markers such as TIMP1, pro-MMP10, PECAM1, proMMP-2, and IGFBP1 were associated with clinical outcomes. Although the result of a small study, a combination of ivaltinostat, gemcitabine, and erlotinib appeared to be a potential treatment option for advanced PDAC.
    P1/2 data • Journal • Tumor Mutational Burden
    |
    TMB (Tumor Mutational Burden) • TIMP1 (Tissue inhibitor of metalloproteinases 1) • CD31 (Platelet and endothelial cell adhesion molecule 1)
    |
    erlotinib • gemcitabine • ivaltinostat IV (CG-745)
    over4years
    HDAC Inhibitor, CG-745, Enhances the Anti-Cancer Effect of Anti-PD-1 Immune Checkpoint Inhibitor by Modulation of the Immune Microenvironment. (PubMed, J Cancer)
    Recent advances in immunotherapy highlight the anti-cancer effects of immune checkpoint inhibitor despite a relatively limited clinical benefit in the subset of patients. Our results indicate that CG-745 enables the synergistic effects of the immune checkpoint inhibitor combination therapy in various cancers by suppressing tumor microenvironment.
    Journal • Checkpoint inhibition • PD(L)-1 Biomarker
    |
    IL2 (Interleukin 2)
    |
    ivaltinostat IV (CG-745)