9-ING-41 for Advanced Cancers

Not currently recruiting at 73 trial locations

Overseen By Jamil Asselah, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Actuate Therapeutics Inc.

Disqualifiers: Pregnancy, Cardiovascular impairment, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new drug, 9-ING-41 (a GSK-3β inhibitor), for people with advanced cancers that haven't responded well to standard treatments. Researchers are testing 9-ING-41 alone and in combination with other drugs like Paclitaxel, Carboplatin, and Gemcitabine. People with advanced cancer whose current treatments aren't working, or who have experienced cancer recurrence after standard therapy, might be a good fit. This study could offer new hope for those whose cancer has proven difficult to treat with existing options. As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you may continue endocrine therapies and anti-Her2 therapies. There are specific waiting periods for certain treatments like chemotherapy and radiation before starting the study drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that 9-ING-41, a type of medicine, may help treat cancer by stopping cancer cells from growing. Studies have found that 9-ING-41 is generally safe when used alone or with chemotherapy drugs like paclitaxel, carboplatin, gemcitabine, and doxorubicin.

Patients who received 9-ING-41 with chemotherapy experienced manageable and non-severe side effects. Importantly, these studies found no major safety issues, suggesting that 9-ING-41 could be a safe option for those considering joining a clinical trial.

While these results are promising, ongoing studies continue to investigate the complete safety of 9-ING-41. However, current evidence suggests that this treatment is generally well-tolerated in people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about 9-ING-41 because it offers a novel approach to treating advanced cancers. Most treatments target cancer cells directly, but 9-ING-41 works by inhibiting a specific enzyme called GSK-3β, which plays a role in tumor growth and survival. This unique mechanism could potentially enhance the effectiveness of existing chemotherapy drugs like Paclitaxel, Carboplatin, and Gemcitabine, making them more powerful against cancer cells. By targeting a different pathway, 9-ING-41 has the potential to overcome resistance to current treatments and improve outcomes for patients with advanced cancers.

What evidence suggests that this trial's treatments could be effective for advanced cancers?

Research has shown that 9-ING-41, a drug targeting a protein linked to cancer growth, holds promise for treating various cancers. In this trial, participants will receive 9-ING-41 either alone or with other chemotherapy drugs. One treatment arm will test 9-ING-41 with paclitaxel and carboplatin, which has demonstrated benefits and is generally safe. Another arm will evaluate 9-ING-41 combined with gemcitabine, which has effectively killed cancer cells and boosted the immune system. Additional arms will explore combinations with drugs like doxorubicin and irinotecan, offering new ways to treat chemotherapy-resistant cancers. Overall, increasing evidence suggests that 9-ING-41 could help manage hard-to-treat cancers. ^{2 3 5 6 7}

Who Is on the Research Team?

Francis Giles, MD

Principal Investigator

ATI

Steven D Reich, MD

Principal Investigator

Actuate Therapeutics Inc.

Are You a Good Fit for This Trial?

Adults with advanced or metastatic cancer, who have not responded to standard treatments or for whom no treatment improving survival by at least 3 months is available. Participants must be able to consent and follow study procedures, use effective contraception if of childbearing potential, and have adequate organ function.

Inclusion Criteria

My cancer is advanced, and current treatments aren’t working or suitable for me.

Patient is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures

Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first study therapy and agree to use effective contraceptive methods

Exclusion Criteria

Is considered to be a member of a vulnerable population (for example, prisoners)

I do not have severe heart problems or recent strokes.

I have not taken any experimental cancer drugs recently nor am I in another clinical trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Part 1

9-ING-41 as monotherapy with dose escalation to identify MTD/RP2D

3 months to 3 years

Treatment - Part 2

9-ING-41 combined with standard anticancer agents using dose escalation to identify MTD/RP2D

3 months to 3 years

Treatment - Part 3

Randomized Phase 2 study of 9-ING-41 with gemcitabine and nab-paclitaxel versus GA alone

3 months to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• 9-ING-41

Trial Overview The trial tests the safety and effectiveness of a new drug called 9-ING-41 alone or combined with other chemotherapy drugs (like Gemcitabine) in patients whose cancers haven't improved after standard treatment. It's a Phase 1/2 study targeting GSK-3β, an enzyme involved in cancer cell growth.

How Is the Trial Designed?

Group I: 9-ING-41 plus nab paclitaxel Gemcitabine Experimental Treatment 3 Interventions

Drugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.

Group II: 9-ING-41 plus Paclitaxel/Carboplatin Experimental Treatment 3 Interventions

Drugs: Paclitaxel. Carboplatin. 9-ING-41.

Group III: 9-ING-41 plus Lomustine Experimental Treatment 2 Interventions

Drugs: Lomustine. 9-ING-41.

Group IV: 9-ING-41 plus Irinotecan Experimental Treatment 2 Interventions

Drugs: Irinotecan. 9-ING-41.

Group V: 9-ING-41 plus Gemcitabine Experimental Treatment 2 Interventions

Drugs: Gemcitabine - 21 day cycle. 9-ING-41

Group VI: 9-ING-41 plus Doxorubicin Experimental Treatment 2 Interventions

Drugs: Doxorubicin. 9-ING-41

Group VII: 9-ING-41 plus Carboplatin Experimental Treatment 2 Interventions

Drugs: Carboplatin. 9-ING-41.

Group VIII: 9-ING-41 Experimental Treatment 1 Intervention

Drug: 9-ING-41

Who Is Running the Clinical Trial?

Actuate Therapeutics Inc.

Lead Sponsor

Trials

10

Recruited

580+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37982822/

Phase I Study of Elraglusib (9-ING-41), a Glycogen ... ... Advanced Malignancies. Clin Cancer ... Legorreta Cancer Center, Brown University and Lifespan Cancer Institute, Providence, Rhode Island.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03678883

NCT03678883 | 9-ING-41 in Patients with Advanced Cancers Glycogen synthase kinase-3 beta inhibitors as novel cancer treatments and modulators of antitumor immune responses. Cancer Biol Ther. 2019;20(8):1047-1056 ...

3. esmoopen.com esmoopen.com/article/S2059-7029(25)00991-3/fulltext

Phase II study of elraglusib (9-ING-41), a GSK-3β inhibitor ... ... outcomes in patients with advanced pancreatic cancer who receive modified FOLFIRINOX therapy. Cancers (Basel). 2018; 10:454. Crossref · Scopus ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.4_suppl.578

Phase 2 study of 9-ING-41, a small molecule selective ... Prognostic factors associated with survival in patients with pancreatic cancer treated on early phase immune-checkpoint inhibitor clinical ...

5. aacrjournals.org aacrjournals.org/mct/article/24/10_Supplement/B079/766254/Abstract-B079-The-glycogen-synthase-kinase-3

The glycogen synthase kinase-3β inhibitor 9-ING-41 in ... 9-ING-41 (Elraglusib), a GSK-3β inhibitor with clinical activity in adult cancers, is effective as a single agent in neuroblastoma animal ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03678883

NCT03678883 | 9-ING-41 in Patients with Advanced Cancers Glycogen synthase kinase-3 beta inhibitors as novel cancer treatments and modulators of antitumor immune responses. Cancer Biol Ther. 2019;20(8):1047-1056 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6984786/

Clinically relevant GSK-3β inhibitor 9-ING-41 is active as a ... In renal cancer cell lines, treatment with 9-ING-41 alone induced cell cycle arrest and apoptosis, and autophagy inhibitors increased the antitumor effects of 9 ...