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Glycogen Synthase Kinase-3 Beta Inhibitor

9-ING-41 for Pediatric Cancer

Phase 1

Recruiting

Research Sponsored by Actuate Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have Performance Level: Karnofsky ≥ 50% for patients >16 years of age and Lansky ≥50 for patients ≤16 years of age

Age < 22 years of age

Must not have

Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia, infertility and ototoxicity. Recovery is defined as ≤ Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0)

Has clinically significant retinal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether 9-ING-41 can shrink tumors in kids with cancer without causing serious side effects.

Who is the study for?

This trial is for children and young adults under 22 with various advanced cancers, including brain tumors and neuroblastoma. Participants must have tried at least one treatment before, be in a stable condition, and have a certain level of physical ability. Pregnant individuals or those with uncontrolled illnesses, prior organ transplants, or severe reactions to the drugs being tested cannot join.

What is being tested?

The study tests the drug 9-ING-41's effectiveness in pediatric patients with cancer that hasn't responded to other treatments. It will be given alongside existing chemotherapy drugs like Temozolomide and Irinotecan to see if it improves outcomes without significant toxicity.

What are the potential side effects?

While not detailed here, potential side effects may include typical chemotherapy-related issues such as nausea, fatigue, hair loss (except alopecia), blood cell count changes leading to increased infection risk or bleeding problems; specific drug sensitivities could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am mostly able to care for myself, regardless of my age.

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I am younger than 22 years old.

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My condition has no cure or treatments that would extend life with good quality.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have recovered from previous cancer treatment side effects, except for hair loss, infertility, or hearing loss.

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I have a serious eye condition affecting my retina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with treatment-related adverse events as assessed by CTCAE v5

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: 9-ING-41 plus Irinotecan plus TemozolomideExperimental Treatment3 Interventions

9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Irinotecan will be administered at a dose of 50 mg/m2/day over 90 minutes IV on days 1-5 every 21 days. Temozolomide will be administered at a dose of 100 mg/m2/dose by mouth on Days 1 through 5 ((cycle duration is 21 days).

Group II: 9-ING-41 plus IrinotecanExperimental Treatment2 Interventions

Group III: 9-ING-41 plus Cyclophosphamide plus TopotecanExperimental Treatment3 Interventions

Cyclophosphamide 400 mg/m2/dose administered intravenously over 30 min on Days 1 through 5. Topotecan 1.2 mg/m2/dose administered intravenously over 30 min once on Days 1 through 5. 9-ING-41 intravenous infusion twice weekly (cycle duration is 21 days).

Group IV: 9-ING-41Experimental Treatment1 Intervention

9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Cycle duration is 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irinotecan

2017

Completed Phase 3

~2590

9-ING-41

2020