Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma

9-ING-41 is a small molecule potent selective GSK-3β inhibitor with antitumor activity. This study investigates 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC). Patients with advanced SGC (including all histologic subtypes and adenoid cystic carcinoma [ACC]) will receive 9-ING-41 intravenously (IV) along with carboplatin IV at standard dosing together on Day 1, and 9-ING-41 alone on Day 4 of a 21-day cycle. Participants will be enrolled to two histologic cohorts: Cohort 1 will be comprised of those with ACC, and Cohort 2 will include patients with non-ACC SGC (or all other salivary gland cancer histologies). Treatment will continue until progression of disease, death, or discontinuation of therapy for any reason.

Start Date18 Dec 2030

Sponsor / Collaborator

Actuate Therapeutics, Inc.

NCT06896188

/ Not yet recruitingPhase 1IIT

A Phase Ib Study of 9-ING-41 (elraglusib), a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined with Retifanlimab, a PD-1 Inhibitor, Plus Modified FOLFIRINOX As Frontline Therapy for Patients with Advanced Pancreatic Adenocarcinoma (RiLEY)

This is a study of the combination of 9 ING-41 (elraglusib) and retifanlimab plus mFOLFIRINOX in patients with pancreatic cancer without prior systemic therapy for advanced disease. The safety lead-in cohort will consist of 6 patients, followed by dose de-escalation if necessary, based on safety assessments. After evaluating the safety and tolerability at the initial dose level, the study will proceed to an expansion cohort at the determined safe dose level, with the total maximum enrollment not exceeding 12 patients for the entire study.

Start Date31 May 2025

Sponsor / Collaborator

University of Pittsburgh

[+2]

NCT05077800

/ RecruitingPhase 2IIT

A Phase II Study of FOLFIRINOX Combined With the Glycogen Synthase Kinase-3 Beta (GSK-3 β) Inhibitor 9-ING-41 and the Transforming Growth Factor-β (TGF-β) Inhibitor Losartan in Patients With Untreated Metastatic Pancreatic Cancer

The purpose of this study is to find out if an experimental drug will prevent metastatic pancreatic adenocarcinoma from becoming resistant to standard treatment for the disease.
The names of the study drugs involved in this study are:
* 9-ING-41
* Losartan
* Ferumoxytol
* FOLFIRINOX (made up of 4 different drugs):
* 5-Fluorouracil (5-FU)
* Oxaliplatin
* Irinotecan
* Leucovorin

Start Date21 Mar 2022

Sponsor / Collaborator

Actuate Therapeutics, Inc.

[+1]

100 Clinical Results associated with Elraglusib

100 Translational Medicine associated with Elraglusib

100 Patents (Medical) associated with Elraglusib

Literatures (Medical) associated with Elraglusib

01 Dec 2024·EUROPEAN JOURNAL OF HAEMATOLOGY

A New Strategy for Adult T‐Cell Leukemia Treatment Targeting Glycogen Synthase Kinase‐3β

Article

Author: Ishikawa, Chie ; Mori, Naoki

ABSTRACT:

Objectives:

The role of glycogen synthase kinase (GSK)‐3β in adult T‐cell leukemia (ATL) caused by human T‐cell leukemia virus type 1 (HTLV‐1) is paradoxical and enigmatic. Here, we investigated the role of GSK‐3β and its potential as a therapeutic target for ATL.

Methods:

Cell proliferation/survival, cell cycle, apoptosis, and reactive oxygen species (ROS) generation were examined using the WST‐8 assay, flow cytometry, and Hoechst 33342 staining, respectively. Expression of GSK‐3β and cell cycle/death‐related proteins, and survival signals was analyzed using RT‐PCR, immunofluorescence staining, and immunoblotting.

Results:

HTLV‐1‐infected T‐cell lines showed nuclear accumulation of GSK‐3β. GSK‐3β knockdown and its inhibition with 9‐ING‐41 and LY2090314 suppressed cell proliferation/survival. 9‐ING‐41 induced G2/M arrest by enhancing the expression of γH2AX, p53, p21, and p27, and suppressing the expression of CDK1, cyclin A/B, and c‐Myc. It induced caspase‐mediated apoptosis by decreasing the expression of Bcl‐xL, Mcl‐1, XIAP, c‐IAP1/2, and survivin, and increasing the expression of Bak and Bax. 9‐ING‐41 also induced ferroptosis and necroptosis, promoted JNK phosphorylation, and suppressed IKKγ and JunB expression. It inhibited the phosphorylation of IκBα, Akt, and STAT3/5, induced ROS production, and reduced glycolysis‐derived lactate levels.

Conclusion:

GSK‐3β functions as an oncogene in ATL and could be a potential therapeutic target.

01 Nov 2024·Cancer research communications

Elraglusib Induces Cytotoxicity via Direct Microtubule Destabilization Independently of GSK3 Inhibition

Article

Author: Sutherland, Calum ; Tanaka, Tomoyuki U. ; Saurin, Adrian T. ; Li, Shuyu ; Tauro, Sudhir ; Coats, Josh T.

Abstract:

Elraglusib (9-ING-41) is an ATP-competitive inhibitor of glycogen synthase kinase-3 (GSK3) with preclinical studies demonstrating broad activity against many tumor types. Promising early-phase clinical trial data led to FDA orphan drug status, and a randomized phase II study in combination with cytotoxic chemotherapy in pancreatic cancer has recently completed its recruitment. Similarly, single-agent responses in adult T-cell leukemia/lymphoma and melanoma and combination treatment data in several other tumor types have been encouraging. The elraglusib mechanism of action is unknown, but it is unlikely to act through GSK3 inhibition because cytotoxicity is observed below the IC50 for GSK3, and other small molecule GSK3 inhibitors do not produce cytotoxic effects, at least in lymphoma cells. We show here that elraglusib perturbs chromosomal alignment to cause a mitotic arrest in multiple tumor lines. This arrest is caused by direct microtubule (MT) depolymerization, which prevents the attachment of kinetochores to MTs. At clinically relevant doses, these mitotically arrested cells eventually undergo mitotic slippage, leading to gross chromosome missegregation, DNA damage, and apoptosis. These effects explain the cytotoxicity of elraglusib because temporarily pausing cell-cycle progression with the CDK4/6 inhibitor palbociclib abolishes any drug-induced genotoxicity and apoptosis. In summary, elraglusib acts as a direct MT destabilizer both in vitro and across multiple cancer types, resulting in mitotic arrest, DNA damage, and apoptosis. These effects likely account for its broad pan-cancer activity, which does not rely upon GSK3 inhibition as they are not replicated by other GSK3 inhibitors.

Significance::

Elraglusib was designed as a GSK3 inhibitor and is currently in clinical trials for several cancers. We show conclusively that the target of elraglusib that leads to cytotoxicity is MTs and not GSK3. This has significant implications for ongoing clinical trials of the compound and will help in understanding off-target side effects, inform future clinical trial design, and facilitate the development of biomarkers to predict response.

01 Jun 2024·JHEP Reports

Glycogen synthase kinase 3 activity enhances liver inflammation in MASH

Article

Author: Kim, Iljung ; Islam, Shahidul ; Pavelko, Kevin D ; Mazar, Andrew P ; Warasnhe, Khaled ; Li, Hu ; Bamidele, Adebowale O ; Noh, Yung-Kyun ; Ibrahim, Samar H ; Kim Lee, Hyun Se ; Holmes, Heather ; Furuta, Kunimaro ; Valenzuela-Pérez, Lucía ; Guo, Qianqian ; Romero, Michael F ; Khoury, Mireille ; Correia, Cristina ; Sussman, Caroline R ; Meroueh, Chady ; Hirsova, Petra

Background & Aims:

Metabolic dysfunction-associated steatohepatitis (MASH) is characterized by excessive circulating toxic lipids, hepatic steatosis, and liver inflammation. Monocyte adhesion to liver sinusoidal endothelial cells (LSECs) and transendothelial migration (TEM) are crucial in the inflammatory process. Under lipotoxic stress, LSECs develop a proinflammatory phenotype known as endotheliopathy. However, mediators of endotheliopathy remain unclear.

Methods:

Primary mouse LSECs isolated from C57BL/6J mice fed chow or MASH-inducing diets rich in fat, fructose, and cholesterol (FFC) were subjected to multi-omics profiling. Mice with established MASH resulting from a choline-deficient high-fat diet (CDHFD) or FFC diet were also treated with two structurally distinct GSK3 inhibitors (LY2090314 and elraglusib [9-ING-41]).

Results:

Integrated pathway analysis of the mouse LSEC proteome and transcriptome indicated that leukocyte TEM and focal adhesion were the major pathways altered in MASH. Kinome profiling of the LSEC phosphoproteome identified glycogen synthase kinase (GSK)-3β as the major kinase hub in MASH. GSK3β-activating phosphorylation was increased in primary human LSECs treated with the toxic lipid palmitate and in human MASH. Palmitate upregulated the expression of C-X-C motif chemokine ligand 2, intracellular adhesion molecule 1, and phosphorylated focal adhesion kinase, via a GSK3-dependent mechanism. Congruently, the adhesive and transendothelial migratory capacities of primary human neutrophils and THP-1 monocytes through the LSEC monolayer under lipotoxic stress were reduced by GSK3 inhibition. Treatment with the GSK3 inhibitors LY2090314 and elraglusib ameliorated liver inflammation, injury, and fibrosis in FFC- and CDHFD-fed mice, respectively. Immunophenotyping using cytometry by mass cytometry by time of flight of intrahepatic leukocytes from CDHFD-fed mice treated with elraglusib showed reduced infiltration of proinflammatory monocyte-derived macrophages and monocyte-derived dendritic cells.

Conclusion:

GSK3 inhibition attenuates lipotoxicity-induced LSEC endotheliopathy and could serve as a potential therapeutic strategy for treating human MASH.

Impact and Implications:

LSECs under lipotoxic stress in MASH develop a proinflammatory phenotype known as endotheliopathy, with obscure mediators and functional outcomes. The current study identified GSK3 as the major driver of LSEC endotheliopathy, examined its pathogenic role in myeloid cell-associated liver inflammation, and defined the therapeutic efficacy of pharmacological GSK3 inhibitors in murine MASH. This study provides preclinical data for the future investigation of GSK3 pharmacological inhibitors in human MASH. The results of this study are important to hepatologists, vascular biologists, and investigators studying the mechanisms of inflammatory liver disease and MASH, as well as those interested in drug development.

News (Medical) associated with Elraglusib

22 May 2025

·actuatetherapeutics.com

Actuate Therapeutics Announces Details for 2025 ASCO Annual Meeting Presentation on Topline Elraglusib Phase 2 Data in First-Line Treatment of Metastatic Pancreatic Cancer

Phase 2 (Actuate-1801 Part 3B) trial topline results meet primary endpoint of improved survival in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) Oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting to highlight statistically significant improvement in median overall survival and 1-year survival rate in patients treated with the combination of elraglusib and gemcitabine/nab-paclitaxel (GnP) compared to GnP alone Company to host KOL event on May 31, 2025, to review data presented CHICAGO and FORT WORTH, Texas, May 22, 2025 (GLOBE NEWSWIRE) — Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced the online publication of the abstract accepted as an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place May 30-June 3, in Chicago, Illinois. The oral presentation will highlight topline Phase 2 (Actuate-1801 Part 3B) data of elraglusib in combination with GnP in first-line mPDAC and will be presented by Devalingam Mahalingam, MD, PhD, of Northwestern University Feinberg School of Medicine. The topline data demonstrate clinically meaningful and consistent improvements across primary efficacy measures compared to treatment with GnP alone and reinforce the potential of elraglusib to address key unmet needs in this patient population. The published abstract describes preliminary results reported in December 2024, demonstrating that treatment with elraglusib in combination with GnP resulted in statistically significant increases in 1-year survival rate and median overall survival versus treatment with GnP alone. The combination treatment also resulted in increased Objective Response Rates (ORR) and Disease Control Rates (DCR) in the elraglusib/GnP combination arm versus the GnP control arm. “Metastatic PDAC patients are known to have poor prognosis,” said Daniel Schmitt, President & Chief Executive Officer of Actuate. “Reaching statistical significance in increased survival in a Phase 2 trial of this scale is an exceptional achievement and speaks to the strength of elraglusib’s clinical activity. The data have only grown more compelling with time, and we believe this positions elraglusib as one of the most promising emerging therapies in mPDAC, and as a highly valuable, late-stage asset with clear regulatory and significant commercial potential. We are incredibly excited to have the topline dataset presented at ASCO.” ASCO Presentations Details: Abstract Title: Preliminary results from the randomized phase 2 study (1801 Part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).Abstract Number: 4006Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and HepatobiliaryPresenter: Devalingam Mahalingam, MD, PhDOral Presentation Date and Time: Saturday, May 31, 2025, 4:48 PM CDT Abstract Title: Machine learning and statistical prediction of overall survival (OS) from pre-dose plasma biomarkers in a randomized phase 2 trial (1801 Part 3B) of the GSK-3 inhibitor elraglusib in metastatic pancreatic ductal adenocarcinoma (mPDAC): Application toward patient enrichment.Abstract Number: 4185Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and HepatobiliaryPoster Presentation Date and Time: Saturday, May 31, 2025, 9:00 AM – 12:00 PM CDT The abstracts are available on the ASCO website at https://conferences.asco.org/am/abstracts KOL Event Actuate will host a KOL event for the investment community on Saturday, May 31, 2025, at 6:30 PM CDT to review the data. The webinar will feature a fireside discussion moderated by Daniel Schmitt, President & Chief Executive Officer of Actuate, and will include four distinguished KOLs: Tanios Bekaii-Saab, MD, FACP, Mayo Clinic College of Medicine and Science, Devalingam Mahalingam, MD, Northwestern University Feinberg School of Medicine, Rachna Shroff, MD, MS, FASCO, University of Arizona Cancer Center, and Colin Weekes, MD, PhD, Massachusetts General Hospital. A replay of the event will be available on the Investor Relations section of the Actuate website. The Actuate-1801 Part 3β study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and AE. Inhibition of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity, and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT). About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. For additional information, please visit the Company’s website at http://www.actuatetherapeutics.com. Forward-Looking Statements This press release contains forward-looking statements about us, including our and other parties’ clinical trials and development plans, and our industry. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. All statements, other than statements related to present facts or current conditions or of historical facts, contained in this press release are forward-looking statements. Accordingly, these statements involve estimates, assumptions, substantial risks and uncertainties which could cause actual results to differ materially from those expressed in them, including but not limited to that preliminary and unpublished data may be subject to change and further interpretation following the availability of more data or following a more comprehensive review of the data and should not be relied upon as a final analysis; clinical and preclinical drug development involves a lengthy and expensive process with uncertain timelines and outcomes, results of prior preclinical studies and early clinical trials are not necessarily predictive of future results, and elraglusib may not achieve positive clinical results or favorable preclinical results or receive regulatory approval on a timely basis, if at all; that we may not successfully enroll additional patients or establish or advance plans for further development, including through conversations with the FDA or EMA and the standards such bodies may impose for such development; that elraglusib could be associated with side effects, adverse events or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials or result in other negative consequences; our reliance on third parties to conduct our non-clinical studies and our clinical trials; our reliance on third-party licensors and ability to preserve and protect our intellectual property rights; that we face significant competition from other biotechnology and pharmaceutical companies; our ability to fund development activities, including because our financial condition raises substantial doubt as to our ability to continue as a going concern and we require additional capital to finance our operations beyond the second quarter of fiscal year 2025, and a failure to obtain this necessary capital in the near term on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our development programs, commercialization efforts or other operations. In addition, any forward-looking statements are qualified in their entirety by reference to the factors discussed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025 and other filings with the SEC. Because the risk factors referred to above could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Unless legally required, we do not undertake any obligation to release publicly any revisions to such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events. Investor Contact Mike Moyer Managing Director LifeSci Advisors, LLC mmoyer@lifesciadvisors.com

Phase 2Clinical ResultASCOImmunotherapy

05 May 2025

·www.globenewswire.com

Actuate to Present Elraglusib Phase 2 Topline Data at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting

- Oral presentation at ASCO to highlight topline Phase 2 data of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) April 23, 2025 -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced that topline clinical data from the randomized Phase 2 study (Actuate-1801 Part 3B) evaluating elraglusib have been selected for oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, to take place May 30- June 3, in Chicago, Illinois. Abstract Title: Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Abstract Number: 4006 Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary Session Date and Time: Saturday, May 31, 2025, 3:00 PM-6:00 PM CDT Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. The content above comes from the network. if any infringement, please contact us to modify.

ASCOClinical Result

22 Apr 2025

·www.globenewswire.com

Actuate to Present Promising Data on Elraglusib in Advanced Salivary Gland Carcinoma at the AACR Annual Meeting 2025

April 17, 2025 -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company, focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), today announced that data on elraglusib in advanced salivary gland carcinoma will be presented in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2025 taking place from April 25th – 30th at McCormick Place Convention Center, Chicago, IL. The abstracts will be published in the online Proceedings of the AACR. Poster presentation details: Title: Elraglusib, a glycogen synthase kinase 3 beta (GSK-3β) inhibitor, plus chemotherapy with or without immunotherapy for advanced salivary gland cancer Session Title: Phase II Clinical Trials 2 Session Date and Time: April 29, 2025, 2:00 PM - 5:00 PM Location: Poster Section 50 Abstract Presentation Number: CT212 "Elraglusib with chemotherapy and immune priming represents a novel sequential therapy approach to treat advanced salivary cancers. We were encouraged by the response rate among the non-Adenoid Cystic Carcinoma (ACC) population with nuclear GSK-3β overexpression given this difficult to treat and rare cancer type", said Dr. Glenn Hanna, Director of the Center for Cancer Therapeutic Innovation (CCTI), the early drug development program at Dana Farber Cancer Institute, who led the team conducting this clinical study. Separately, an independent research group led by Dr. Wafik S El-Deiry from Legorreta Cancer Center at Brown University will present a poster demonstrating the synergistic effects of elraglusib in combination with ONC206 or ONC212, investigational compounds from Jazz Pharmaceuticals plc. Poster presentation details: Title: Elraglusib (9-ING-41), a glycogen synthase kinase-3β inhibitor in combination with imipridones for treatment of solid cancer Session Title: Drug Combination Strategies for Cancer Treatment Session Date and Time: April 28, 2025, 9:00 AM - 12:00 PM Location: Poster Section Poster Section 19 Abstract Presentation Number: 1693 About Actuate Therapeutics, Inc. Actuate is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers. Actuate’s lead investigational drug, elraglusib (a novel GSK-3β inhibitor), targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy through the inhibition of nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and DNA Damage Response (DDR). Elraglusib may also mediate anti-tumor immunity through the regulation of multiple immune checkpoints and immune cell function. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyAACR

100 Deals associated with Elraglusib

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16047

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic melanoma	Phase 2	United States	Actuate Therapeutics, Inc.	31 May 2023
Metastatic melanoma	Phase 2	United States	Lantern Pharma, Inc.	31 May 2023
Metastatic Pancreatic Cancer	Phase 2	United States	Actuate Therapeutics, Inc.	21 Mar 2022
Pancreatic adenocarcinoma metastatic	Phase 2	United States	Actuate Therapeutics, Inc.	21 Mar 2022
Metastatic osteosarcoma	Phase 2	United States	Actuate Therapeutics, Inc.	01 Mar 2022
Small Cell Sarcoma	Phase 2	United States	Actuate Therapeutics, Inc.	01 Mar 2022
Advanced Pancreatic Adenocarcinoma	Phase 2	United States	Actuate Therapeutics, Inc.	26 Jan 2022
Advanced Pancreatic Adenocarcinoma	Phase 2	United States	Incyte Corp.	26 Jan 2022
Pancreatic Ductal Adenocarcinoma	Phase 2	United States	Actuate Therapeutics, Inc.	26 Jan 2022
Pancreatic Ductal Adenocarcinoma	Phase 2	United States	Incyte Corp.	26 Jan 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03678883 (Actuate-1801 Part 3B, GlobeNewswire) Manual	Phase 2	Metastatic Pancreatic Cancer First line	-	elraglusib + gemcitabine/nab-paclitaxel (GnP)	bvgetddvcc(wfvgursfnv) = elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results. cnwacqdiun (bgnqxzqwje ) Met	Positive	09 May 2025
				gemcitabine/nab-paclitaxel (GnP)
NCT05010629 (AACR2025)	Phase 2	Salivary Gland Neoplasms tumor PD-L1 \| GSK-3β expression	32	Elraglusib	nwcedmuicy(xtbcszufdp) = buyfhdhucn zmhffjyamm (vcxyrgmbyy, 2 - 25) View more	Positive	29 Apr 2025
NCT04239092 (Actuate-1801, GlobeNewswire) Manual	Phase 2	Pancreatic Cancer First line	286	Elraglusib + gemcitabine/nab-paclitaxel	wcailwwaqd(tjzscfkseh) = nrmwkyesyv xucefklwqq (qsxrnrznjm ) Met View more	Positive	17 Dec 2024
				gemcitabine/nab-paclitaxel	wcailwwaqd(tjzscfkseh) = hscrkhotad xucefklwqq (qsxrnrznjm ) Met View more
NCT04239092 (GlobeNewswire) Manual	Phase 1/2	Ewing Sarcoma \| Desmoplastic Small Round Cell Tumor	8	elraglusib	ehixuxdqce(wxgqqjdjbb) = oxkuimrjmt mhxdajpxip (gwofrjpegx ) View more	Positive	09 Sep 2024
NCT03678883 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Advanced Pancreatic Ductal Adenocarcinoma	42	gemcitabine+Albumin-Bound Paclitaxel+Elraglusib	iztlpboxcd(tledgtprkn) = ozlrbtukzg mpebbvxhal (dohqzdyfhn, 32.5 - 70.6) View more	Positive	26 May 2023
NCT03678883 (AACR2023) Manual	Phase 1/2	Advanced cancer Third line	-	elraglusib (melanoma)	noyxyqkmyq(irwyvyvafu) = umbtmzanzx wmqhlccqxu (khgweqwvht )	Positive	14 Apr 2023
				elraglusib (colorectal cancer)	higccszksw(qoswgmigbl) = cjbrqmukfo rlecwjqekd (mkuinmwaob ) View more
NCT04239092 (ASCO2022) Manual	Phase 1/2	Neoplasms	23	ElraglusibElraglusib alone or in combination with chemotherapy	yaokbabars(hafdelabbq) = none bivrhorxoq (fltynrvqur ) View more	Positive	02 Jun 2022
				Elraglusib + cyclophosphamide/topotecan or irinotecan
NCT03678883 (Pubmed) Manual	Phase 1/2	Neoplasms \| Malignant glioma of brain	18	Lomustine+Elraglusib	swnygmpkpv(xcrifzmbtn) = mild vision changes 50%, infusion reactions 22% liaccqblqs (anplwyclgm ) View more	Positive	07 Feb 2022
NCT03678883 (ACTUATE 1801, SNO2021)	Phase 1/2	Glioma IDH \| 1p19q \| MGMT ... View more	18	9-ING-41 monotherapy	yvpjnlucgl(gacnhscyap) = vyvbpehhgw geucsrjqgo (blzhxuleus ) View more	Positive	12 Nov 2021
				9-ING-41 + Lomustine	yulhfsbmec(ttfandkknq) = kyscjsmian nkfpbpbmtu (cqoavarleb ) View more
AACR2021	Not Applicable	Colorectal Cancer	-	9-ING-41	uribrqnxtu(wmofidjiup) = primstkexf ohddewmtwr (wfhiocwdin ) View more	-	01 Jul 2021

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