9-ING-41 for Advanced Cancers

Recruiting at 67 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Actuate Therapeutics Inc.

No Placebo Group

Prior Safety Data

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.

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)

Treatment Details

Interventions

• 9-ING-41 (GSK-3β inhibitor)

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+