9-ING-41 for Advanced Cancers

Recruiting at 67 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

350 Participants Needed

Trial Summary

What is the purpose of this trial?

GSK-3β is a potentially important therapeutic target in human malignancies. The Actuate 1801 Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41, a potent GSK-3β inhibitor, as a single agent and in combination with cytotoxic agents, in patients with refractory cancers.

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.

What data supports the effectiveness of the drug 9-ING-41 for advanced cancers?

Research shows that 9-ING-41, a drug that blocks a protein called GSK-3β, can help stop cancer cells from growing and make them more sensitive to other cancer treatments. It has shown promise in treating different types of cancer, including melanoma, renal cancer, and colorectal cancer, by enhancing the effects of existing therapies and boosting the body's immune response against cancer cells. ^{1 2 3 4 5}

Is 9-ING-41 safe for humans?

9-ING-41, a GSK-3β inhibitor, has been studied in various cancer cell lines and has shown potential as a cancer treatment. While these studies focus on its effectiveness, they do not provide specific safety data for humans. Further clinical trials are needed to determine its safety profile in humans. ^{2 3 4 6 7}

How is the drug 9-ING-41 different from other treatments for advanced cancers?

9-ING-41 is unique because it targets GSK-3β, a protein involved in cancer cell growth and survival, and works by inhibiting this protein to stop cancer cells from multiplying. Unlike traditional chemotherapy, it can enhance the effects of other cancer treatments and boost the immune system's ability to attack cancer cells. ^{1 2 3 4 5}

Research Team

Francis Giles, MD

Principal Investigator

ATI

Steven D Reich, MD

Principal Investigator

Actuate Therapeutics Inc.

Eligibility Criteria

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.

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

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

Exclusion Criteria

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.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Elraglusib (9-ING-41), a selective small-molecule inhibitor of glycogen synthase kinase-3 beta, reduces expression of immune checkpoint molecules PD-1, TIGIT and LAG-3 and enhances CD8+ T cell cytolytic killing of melanoma cells. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Clinically relevant GSK‑3β inhibitor 9‑ING‑41 is active as a single agent and in combination with other antitumor therapies in human renal cancer. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

9-ING-41, a Small Molecule Inhibitor of GSK-3β, Potentiates the Effects of Chemotherapy on Colorectal Cancer Cells. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Glycogen synthase kinase-3 beta inhibitors as novel cancer treatments and modulators of antitumor immune responses. [2020]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Role of glycogen synthase kinase-3β inhibitor AZD1080 in ovarian cancer. [2018]

6. England pubmed.ncbi.nlm.nih.gov

9-ING-41, a small molecule inhibitor of GSK-3beta, potentiates the effects of anticancer therapeutics in bladder cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Inhibition of GSK-3 induces differentiation and impaired glucose metabolism in renal cancer. [2021]