A Phase I, Double Blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'Ivaltinostat' Capsule in Healthy Male Volunteers

A Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male Volunteers

Start Date09 Mar 2023

Sponsor / Collaborator

Machaon Biotherapeutics

NCT05249101 / RecruitingPhase 1/2

A Phase 1b/2, Dose-escalation, Randomized, Multicenter Study of Maintenance Ivaltinostat Plus Capecitabine or Capecitabine in Patients With Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on FOLFIRINOX

This study is a Phase 1b/2, dose-escalation, randomized, multicenter study to assess the efficacy, safety, tolerability, and PK of ivaltinostat in combination with capecitabine and capecitabine monotherapy in patients with metastatic pancreatic adenocarcinoma whose disease has not progressed on a first line fluoropyrimidine-based chemotherapy (e.g., FOLFIRINOX).
In Phase 1b, 3 dose levels of ivaltinostat will be studied in combination with a fixed dose of capecitabine to determine the RP2D of ivaltinostat.
In Phase 2, patients will be randomized in a 1:1 ratio to the combination of ivaltinostat and capecitabine or to capecitabine monotherapy. A fixed dose for capecitabine 1000 mg/m2 orally twice daily will be taken on Days 1 to 14, and the RP2D of ivaltinostat will be administered intravenously once a week for 2 weeks, followed by 1 week of rest. One cycle consists of 21 days. Tumor response during study treatment will be assessed every 6 weeks up to Cycle 10, then every 9 weeks afterwards using RECIST v1.1 criteria.

Start Date15 Aug 2022

Sponsor / Collaborator

CG Pharmaceuticals, Inc.

NCT05345912 / CompletedPhase 1

A Randomized, Double Blind, Placebo-controlled, Dose-escalation, Crossover Study to Compare and Evaluate the Pharmacokinetics and Safety of 'CG-745 IV' Intravenous Formulation and 'CG-750' Capsule Formulation in Healthy Male Adults

A randomized, placebo-controlled, dose-escalation, crossover study.

Start Date16 Dec 2019

Sponsor / Collaborator

CG Invites Co., Ltd.

100 Clinical Results associated with Ivaltinostat

100 Translational Medicine associated with Ivaltinostat

100 Patents (Medical) associated with Ivaltinostat

Literatures (Medical) associated with Ivaltinostat

01 Apr 2024·British journal of clinical pharmacology

Pharmacokinetics, pharmacodynamics and safety of oral formulation (CG‐750) of ivaltinostat, a histone deacetylase inhibitor, compared to IV formulation (CG‐745)

Article

Author: Lee, SeungHwan ; Huh, Ki Young ; Kim, Byungwook ; Yu, Kyung-Sang

Aims:

CG‐750 is an oral formulation of ivaltinostat, a newly developing histone deacetylase (HDAC) inhibitor. This study aimed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of an oral formulation (CG‐750) of ivaltinostat compared to an intravenous (IV) formulation (CG‐745).

Methods:

A randomized, double‐blind, placebo‐controlled study was conducted in three cohorts. Subjects received either CG‐745 (Cohorts 1 and 3: 125 mg; Cohort 2: 250 mg) or placebo followed by CG‐750 (Cohort 1: 125 mg; Cohort 2: 375 mg; Cohort 3: 750 mg) or placebo. Blood samples for PK and PD assessment were collected up to 72 h post‐dose. Histone H3 acetylation at sites K9, K9/K14 and K27 was assessed for area under the % acetylation induction versus time curve (AUEC).

Results:

A total of 25 subjects were randomized, and 23 subjects completed the study (Cohort 1, n = 6; Cohort 2, n = 6; Cohort 3, n = 6; placebo, n = 5). The mean bioavailability of CG‐750 was 10.6% (range: 4.18%–21.33%) and displayed linear PK in the dose range of 125–750 mg. The comparison of AUEC between formulations and the evaluation of the dose–AUEC relationship were inconclusive, due to the small sample sizes and significant variability observed in PD markers. All adverse events (AEs) were transient and of mild or moderate intensity.

Conclusions:

The oral formulation of ivaltinostat (CG‐750) was generally well tolerated after a single dose. CG‐750 displayed a mean bioavailability of 10.6%.

01 Nov 2022·International journal of cancer

A phase I/II study of ivaltinostat combined with gemcitabine and erlotinib in patients with untreated locally advanced or metastatic pancreatic adenocarcinoma

Article

Author: Park, Jeong Youp ; Bang, Seungmin ; Song, Si Young ; Park, Seung Woo ; Cho, Sangsook ; Jo, Jung Hyun ; Lee, Hee Seung ; Chung, Moon Jae ; Park, Soo Been ; Jung, Dawoon E.

Abstract:

This phase I/II study evaluated the safety and efficacy of a new histone deacetylase (HDAC) inhibitor, ivaltinostat, in combination with gemcitabine and erlotinib for advanced pancreatic ductal adenocarcinoma (PDAC). Patients diagnosed with unresectable, histologically confirmed PDAC who had not undergone previous therapy were eligible. Phase I had a 3 + 3 dose escalation design to determine the maximum tolerable dose (MTD) of ivaltinostat (intravenously on days 1, 8 and 15) with gemcitabine (1000 mg/m2 intravenously on days 1, 8 and 15) and erlotinib (100 mg/day, orally) for a 28‐day cycle. In phase II, patients received a six‐cycle treatment with the MTD of ivaltinostat determined in phase I. The primary endpoint was the objective response rate (ORR). Secondary endpoints included overall survival (OS), disease control rate (DCR) and progression‐free survival (PFS). The MTD of ivaltinostat for the phase II trial was determined to be 250 mg/m2. In phase II, 24 patients were enrolled. The median OS and PFS were 8.6 (95% confidence interval [CI]: 5.3‐11.2) and 5.3 months (95% CI: 3.7‐5.8). Of the 16 patients evaluated for response, ORR and DCR were 25.0% and 93.8% with a median OS/PFS of 10.8 (95% CI: 8.3‐16.7)/5.8 (95% CI: 4.6‐6.7) months. 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.

01 Oct 2021·Hypertension (Dallas, Tex. : 1979)Q1 · MEDICINE

Inhibition of HDACs (Histone Deacetylases) Ameliorates High-Fat Diet–Induced Hypertension Through Restoration of the MsrA (Methionine Sulfoxide Reductase A)/Hydrogen Sulfide Axis

Q1 · MEDICINE

Article

Author: Jang, GiBong ; Kim, Jee In ; Park, Kwon Moo ; Jung, Jin Ki ; Kim, InKyeom ; Yoon, Ga-Eun

Graphic Abstract::

An online graphic abstract is available for this article.

News (Medical) associated with Ivaltinostat

29 May 2024

·www.prnewswire.com

CG Pharmaceuticals Prepares to Showcase Its Ongoing Phase 2 Study for Ivaltinostat in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

ORINDA, Calif., May 29, 2024 /PRNewswire/ -- CG Pharmaceuticals, a company dedicated to advancing innovative therapies to improve the lives of patients with cancer, prepares to showcase its advancements in metastatic PDAC therapy. The study design of a randomized multi-center Phase 2 US clinical trial, which is actively enrolling patients, is scheduled to be presented on June 1st, 1:30 – 4:30 PM CDT at the ASCO Annual Meeting (ClinicalTrials.gov NCT05249101). "Metastatic PDAC continues to be an aggressive cancer with limited treatment options. We are pleased that CG Pharmaceuticals is investing in pancreatic cancer research and look forward to the results of their trial," said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at the Pancreatic Cancer Action Network (PanCAN). "Clinical trials are an important aspect of accelerating new developments that improve outcomes for pancreatic cancer patients. PanCAN recommends that patients with PDAC consider participating in clinical trials." In the Phase 1b study, 28 patients with locally advanced or metastatic PDAC who had received at least one prior line of therapy were administered ivaltinostat at three dose levels (60, 125, and 250 mg/m²) in combination with capecitabine. The study demonstrated a favorable safety profile, with no treatment-related serious adverse events. At the time of data cutoff (5/6/2024), 16 patients were alive with 3 patients continuing treatment, and 7 patients were treated for longer than 6 months with the longest duration of treatment of 16 months. The Phase 2 study compares the efficacy of ivaltinostat/capecitabine combination therapy versus capecitabine monotherapy in metastatic PDAC patients who have shown no evidence of disease progression after first-line chemotherapy. Efficacy endpoints include progression-free survival, objective response rate, disease control rate, and overall survival. About Ivaltinostat: Ivaltinostat is a potential first-in-class novel therapeutic candidate for PDAC that inhibits enzymatic activity of histone deacetylase and has been evaluated for solid tumors and hematologic malignancies. CG Pharmaceuticals continues to make strides in its mission to provide innovative treatment options for metastatic PDAC patients. Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them. No forward-looking statements can be guaranteed, and actual results may differ. CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. CG Pharmaceuticals Contact: Douglas An Head of Finance and IR Representative [email protected] SOURCE CG Pharmaceuticals, Inc.

Phase 2Phase 1Clinical Result

06 May 2024

·www.prnewswire.com

CG Pharmaceuticals, Inc. to Present at the 2024 ASCO Annual Meeting in Chicago on June 1st

ORINDA, Calif., May 6, 2024 /PRNewswire/ -- CG Pharmaceuticals, a late-stage clinical biopharmaceutical company specializing in metastatic pancreatic ductal adenocarcinoma (PDAC) maintenance therapy (NCT05249101), will feature one of our investigators, Dr. Christos Fountzilas from Roswell Park Comprehensive Cancer Center, at the ASCO Annual Meeting in Chicago on June 1st, 1:30 – 4:30 PM CDT, during the Gastrointestinal Cancer session (TPS4206). He will be presenting some of the findings from our completed Phase 1b and study design of the on-going Phase 2 clinical trial. Commencement of treatment for the first patient of Phase 2 began on January 9th, 2024, and the study will continue to recruit patients in approximately 25 institutions throughout the US. Continue Reading In the Phase 2 study, metastatic PDAC patients who show no evidence of disease progression after treatment with FOLFIRINOX, mFOLFIRINOX or NALIRIFOX will receive either the ivaltinostat/capecitabine combination therapy or capecitabine monotherapy after randomization. The primary endpoint is to evaluate ivaltinostat's effect on improving progression free survival (PFS), while key secondary endpoints include objective response rate (ORR), disease control rate (DCR), and overall survival (OS). CG Pharmaceuticals, Inc. to Present at the 2024 ASCO Annual Meeting in Chicago on June 1st Post this About Ivaltinostat: Ivaltinostat is a potential first-in-class novel therapeutic candidate for pancreatic ductal adenocarcinoma that inhibits enzymatic activity of histone deacetylase and has been evaluated for solid tumors and hematologic malignancies. About CG Pharmaceuticals: CG Pharmaceuticals is a late-stage clinical biopharmaceutical company that is dedicated to advancing innovative therapies to improve the lives of patients with cancer. CG Pharmaceuticals is located in the San Francisco Bay Area. Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ. The information in this release is provided only as of the written date, and CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. CG Pharmaceuticals Contact: Douglas An Head of Finance and IR Representative [email protected] SOURCE CG Pharmaceuticals, Inc.

Phase 2

18 Nov 2023

·www.prnewswire.com

CG Pharmaceuticals Announces the Commencement of Phase 2 Study for Metastatic Pancreatic Cancer

ORINDA, Calif., Nov. 17, 2023 /PRNewswire/ -- CG Pharmaceuticals announces the commencement of Phase 2 study for metastatic pancreatic ductal adenocarcinoma (PDAC) with the recommended Phase 2 dose (RP2D) of ivaltinostat (ClinicalTrials.gov ID NCT05249101). Continue Reading The RP2D of ivaltinostat (250 mg/m2) was determined by the Safety Review Committee (SRC) following a thorough safety data review from 3 cohorts of increasing dose levels of ivaltinostat in combination with a fixed dose of capecitabine. The SRC has unanimously recommended proceeding to Phase 2, marking a significant milestone, effective immediately, the study is open for the enrollment of patients. CG Pharmaceuticals Announces Commencement of the Phase 2 Metastatic Pancreatic Ductal Adenocarcinoma Study Post this In Phase 2, metastatic PDAC patients who show no evidence of disease progression after an initial treatment with FOLFIRINOX will receive either combination therapy or capecitabine monotherapy. The primary endpoint is progression free survival. Dr. Gene Cho, Vice President of Global Strategic Planning at CG Pharmaceuticals, expressed his excitement, "I am thrilled and honored to share this important study milestone and witness the commencement of Phase 2, with an enrollment target of 52 patients. We extend our heartfelt gratitude to our investigators, partners, and, most importantly, our patients for their invaluable participation in this critical study." The study abstract has been accepted by the ASCO GI and will be presented on January 19, 2024, San Francisco, California. About Ivaltinostat: Ivaltinostat, a novel anticancer therapeutic candidate that inhibits enzymatic activity of histone deacetylase, has been evaluated for solid tumors and hematologic malignancies. About CG Pharmaceuticals: CG Pharmaceuticals, a wholly owned U.S. subsidiary of CG Invites, is dedicated to advancing innovative therapies to improve the lives of patients with cancer. Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ. The information in this release is provided only as of the written date, and CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. CG Pharmaceuticals Contact: Douglas An Head of Finance and IR representative douglas.an@cgxinc.com SOURCE CG Pharmaceuticals, Inc.

Phase 2

100 Deals associated with Ivaltinostat

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pancreatic adenocarcinoma metastatic	Phase 2	US	CG Pharmaceuticals, Inc.	15 Aug 2022
Acute Myeloid Leukemia	Phase 2	KR	CG Invites Co., Ltd.	30 Jan 2022
COVID-19	Phase 2	KR	CG Invites Co., Ltd.	30 Jan 2022
Hepatocellular Carcinoma	Phase 2	KR	CG Invites Co., Ltd.	30 Jan 2022
Myelodysplastic Syndromes	Phase 2	KR	CG Invites Co., Ltd.	30 Jan 2022
Pancreatic Ductal Adenocarcinoma	Phase 2	KR	CG Invites Co., Ltd.	30 Jan 2022
Advanced Pancreatic Adenocarcinoma	Phase 2	KR	CG Invites Co., Ltd.	01 Mar 2016
Secondary malignant neoplasm of pancreas	Phase 2	KR	CG Invites Co., Ltd.	01 Mar 2016
Advanced Malignant Solid Neoplasm	Phase 1	KR	CG Invites Co., Ltd.	01 Sep 2010
Idiopathic Pulmonary Fibrosis	Preclinical	US	CG Invites Co., Ltd.	03 Jan 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SP071 (ERA2018)	Not Applicable	Hypertension	-	CG200745	whkkwemayh(dmmaqzojrc) = kswvaezctc nepwopwxnr (coiodlypsq )	Positive	18 May 2018
SP071 (ERA2018)	Not Applicable	Hypertension	-	CG200745	whkkwemayh(dmmaqzojrc) = ouhhtawlhp nepwopwxnr (coiodlypsq )	Positive	18 May 2018
ASCO2012	Phase 1	HR-positive/HER2-low Solid Tumors	-	CG200745	iyptkgcavz(zbijbxbtnw) = dyymkpkckt kgtxraakmr (enzdrprqpl ) View more	-	20 May 2012

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