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9-ING-41 in Pediatric Patients With Refractory Malignancies.

NCT04239092 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-17

No results posted yet for this study

Summary

9-ING-41 has anti-cancer clinical activity with no significant toxicity in adult patients. This Phase 1 study will study its efficacy in paediatric patients with advanced malignancies.

Conditions

  • Refractory Cancer
  • Refractory Neoplasm
  • Cancer Pediatric
  • Refractory Tumor
  • Pediatric Cancer
  • Pediatric Brain Tumor
  • Neuroblastoma
  • Neuroblastoma Recurrent
  • Pediatric Lymphoma
  • Pediatric Meningioma
  • Diffuse Intrinsic Pontine Glioma

Interventions

DRUG

9-ING-41

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.

DRUG

Irinotecan

Irinotecan 50 mg/m2/day administered over 90 minutes IV on days 1-5 every 21 days.

DRUG

Temozolomide

Temozolomide will be administered at a dose of 100 mg/m2/dose by mouth on Days 1 through 5 of a 21 day cycle.

DRUG

Cyclophosphamide

Cyclophosphamide 400 mg/m2/dose administered intravenously over 30 min on Days 1 through 5 of a 21 day cycle.

DRUG

Topotecan

Topotecan 1.2 mg/m2/dose administered intravenously over 30 min once on Days 1 through 5 of a 21 day cycle.

Sponsors & Collaborators

  • Actuate Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-05
Primary Completion
2025-07-07
Completion
2025-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04239092 on ClinicalTrials.gov