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GSK-3β inhibitor

9-ING-41 for Advanced Cancers

Phase 2
Waitlist Available
Research Sponsored by Actuate Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is aged ≥ 18 years
Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG) PS 0-2
Must not have
Has known symptomatic rapidly progressive brain metastases or leptomeningeal involvement
Has a current active malignancy other than the target cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it is safe and effective in treating cancer. The drug is designed to target a protein called GSK-3β, which is found in many different types of cancer cells.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include those commonly associated with chemotherapy such as fatigue, nausea, hair loss (except alopecia), increased risk of infection due to low blood counts, possible allergic reactions to the drug components, and other organ-specific inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have fast-growing brain tumors or cancer in the lining of my brain.
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I have another active cancer besides the one being targeted.
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I have recovered from side effects of cancer treatment, except for hair loss or infertility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 3 Arm B
Parts 1/2: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: 9-ING-41 plus nab paclitaxel GemcitabineExperimental Treatment3 Interventions
Drugs: Nab-paclitaxel. Gemcitabine - 28 day cycle. 9-ING-41.
Group II: 9-ING-41 plus Paclitaxel/CarboplatinExperimental Treatment3 Interventions
Drugs: Paclitaxel. Carboplatin. 9-ING-41.
Group III: 9-ING-41 plus LomustineExperimental Treatment2 Interventions
Drugs: Lomustine. 9-ING-41.
Group IV: 9-ING-41 plus IrinotecanExperimental Treatment2 Interventions
Drugs: Irinotecan. 9-ING-41.
Group V: 9-ING-41 plus GemcitabineExperimental Treatment2 Interventions
Drugs: Gemcitabine - 21 day cycle. 9-ING-41
Group VI: 9-ING-41 plus DoxorubicinExperimental Treatment2 Interventions
Drugs: Doxorubicin. 9-ING-41
Group VII: 9-ING-41 plus CarboplatinExperimental Treatment2 Interventions
Drugs: Carboplatin. 9-ING-41.
Group VIII: 9-ING-41Experimental Treatment1 Intervention
Drug: 9-ING-41
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lomustine
2008
Completed Phase 3
~1690
Irinotecan
2017
Completed Phase 3
~2590
9-ING-41
2020
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Actuate Therapeutics Inc.Lead Sponsor
8 Previous Clinical Trials
222 Total Patients Enrolled
Francis Giles, MDStudy ChairATI
2 Previous Clinical Trials
279 Total Patients Enrolled
Steven D Reich, MDStudy ChairActuate Therapeutics Inc.
7 Previous Clinical Trials
297 Total Patients Enrolled

Media Library

9-ING-41 (GSK-3β inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03678883 — Phase 2
Bone Tumors Research Study Groups: 9-ING-41 plus Paclitaxel/Carboplatin, 9-ING-41 plus Gemcitabine, 9-ING-41 plus Doxorubicin, 9-ING-41 plus Carboplatin, 9-ING-41 plus nab paclitaxel Gemcitabine, 9-ING-41 plus Irinotecan, 9-ING-41, 9-ING-41 plus Lomustine
Bone Tumors Clinical Trial 2023: 9-ING-41 Highlights & Side Effects. Trial Name: NCT03678883 — Phase 2
9-ING-41 (GSK-3β inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03678883 — Phase 2
~5 spots leftby Jan 2025
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