9-ING-41 + Carboplatin for Salivary Gland Cancer

Not currently recruiting at 1 trial location

Overseen By Glenn J. Hanna, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Glenn J. Hanna

Must not be taking: Anticoagulants

Disqualifiers: CNS metastases, Uncontrolled illness, Pregnant, 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: 3

Duration: Up to 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for advanced salivary gland cancer using an IV medication, 9-ING-41 (a GSK-3β inhibitor), alongside the chemotherapy drug carboplatin. The goal is to determine if this combination can improve outcomes for patients with recurrent, metastatic, or advanced salivary gland cancer that cannot be surgically removed. Participants must have a confirmed diagnosis of salivary gland cancer with signs of disease progression or new symptoms. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot take other cancer-specific treatments or investigational drugs during the study. It's best to discuss your current medications with the trial team to get specific guidance.

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

Research has shown that the combination of 9-ING-41 and carboplatin is under study for its potential to slow the growth of salivary gland cancers. Patients have generally tolerated 9-ING-41 well, although research is ongoing. Studies have not identified any major safety issues with this drug, but common side effects like tiredness or mild nausea have been reported.

Carboplatin, a well-known chemotherapy drug, has FDA approval for treating various cancers. Its safety is well-documented, with common side effects including low blood cell counts and nausea, which are usually manageable.

Overall, existing studies consider both treatments fairly safe, but monitoring for side effects is important. Participants should consult their doctors for personalized advice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about 9-ING-41 combined with carboplatin for salivary gland cancer because 9-ING-41 is a novel drug that targets a protein called GSK-3β, which is involved in cancer cell survival and proliferation. This mechanism is different from the typical chemotherapy approaches that primarily target rapidly dividing cells. By specifically inhibiting GSK-3β, 9-ING-41 may enhance the effectiveness of carboplatin, a standard chemotherapy drug, and potentially overcome resistance seen in traditional treatments. This combination could offer a new avenue for patients, especially those with adenoid cystic carcinoma, where treatment options are limited.

What evidence suggests that 9-ING-41 + carboplatin could be an effective treatment for salivary gland cancer?

Studies have shown that 9-ING-41, a drug that blocks a specific protein, may help stop tumors from growing. This trial tests 9-ING-41 in combination with carboplatin, a common chemotherapy drug used to fight cancer. Although 9-ING-41 has not always met its primary goals in trials, it shows promise when combined with carboplatin for treating salivary gland cancers. Carboplatin alone has been used for various cancers, but its effectiveness can vary. Some research suggests carboplatin may not work as well as other similar drugs. This trial studies the potential of these combined treatments to address advanced salivary gland cancers. ^{1 2 3 4 6}

Who Is on the Research Team?

Glenn J. Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults with advanced salivary gland cancer, including adenoid cystic carcinoma, who have not responded to previous treatments or whose disease has returned. They must be in relatively good health with proper organ and bone marrow function, able to provide tissue samples, and willing to use effective contraception.

Inclusion Criteria

At least one RECIST v1.1 measurable non-CNS based lesion

I have recovered from the side effects of my last cancer treatment.

My scans show new or worsening cancer spots within the last year.

Exclusion Criteria

I have another cancer that is getting worse or needs treatment.

Pregnant or lactating women

I have cancer that has spread to my brain or surrounding membranes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 9-ING-41 and carboplatin chemotherapy every 21 days for up to 1 year

Up to 1 year

Visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year

Open-label extension (optional)

Participants may continue treatment beyond 1 year if showing benefit

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• 9-ING-41
• Carboplatin

Trial Overview The trial is testing the effectiveness of a new drug called 9-ING-41 (a GSK-3β inhibitor) when given through IV alongside Carboplatin chemotherapy. The goal is to see if this combination can help treat advanced salivary gland cancers more effectively.

How Is the Trial Designed?

Group I: 9-ING-41 + carboplatin Experimental Treatment 2 Interventions

Participants will be divided into 2 cohorts: Salivary Gland Cancer with adenoid cystic carcinoma (ACC) and Salivary Gland Cancer without adenoid cystic carcinoma (ACC) and receive: * 9-ING-41 2x every 21 day study cycle on Day 1 and Day 4 up to 1 year with option to continue beyond if participant is showing benefit * Carboplatin 1x every 21 day study cycle on Day 1 up to 1 year

Who Is Running the Clinical Trial?

Glenn J. Hanna

Lead Sponsor

Trials

6

Recruited

160+

Actuate Therapeutics Inc.

Industry Sponsor

Trials

10

Recruited

580+

Citations

1. aacrjournals.org aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-2731/766157/Elraglusib-a-glycogen-synthase-kinase-3-GSK-3

Elraglusib, a glycogen synthase kinase-3β (GSK-3β) inhibitor ... Median nGSK-3β expression was 50% vs. 2% for responders vs. non-responders. Conclusion(s): The trial did not meet its primary endpoint, though ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04832438

NCT04832438 | 9-ING-41 Plus Carboplatin in Patients With ... This study investigates 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC) ...

3. dana-farber.org dana-farber.org/clinical-trials/21-235

Phase 2 study of 9-ING-41, a Glycogen Synthase Kinase-3 ... 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11782928/

Current landscape and future directions of therapeutic ... Adenoid cystic carcinoma (ACC) of the salivary glands is the second most common type of salivary gland cancer, and is characterized by a poor prognosis and ...

5. onclive.com onclive.com/view/dr-hanna-on-elraglusib-plus-chemotherapy-and-immunotherapy-in-advanced-salivary-gland-cancer

Dr Hanna on Elraglusib Plus Chemotherapy and ... Hanna, MD, discusses the efficacy of elraglusib plus chemotherapy with or without immunotherapy in patients with advanced salivary gland cancer.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05010629

9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma It is believed that GSK-3β is over-expressed in salivary gland cancers and by blocking the action of GSK-3β protein with 9-ING-41 it could slow salivary cancer ...