9-ING-41 + Carboplatin for Salivary Gland Cancer

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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called 9-ING-41 for patients with advanced salivary gland cancers that don't respond to usual treatments. The new drug aims to slow down the cancer by blocking a specific function that helps cancer cells grow.

Research Team

Glenn J. Hanna, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+