9-ING-41 in Patients With Advanced Cancers

Summary

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.

Conditions

• Cancer
• Pancreatic Cancer
• Sarcoma
• Renal Cancer
• Refractory Cancer
• Refractory Neoplasm
• Refractory Non-Hodgkin Lymphoma
• Pancreatic Adenocarcinoma
• Resistant Cancer
• Neoplasm Metastasis
• Neoplasm of Bone
• Neoplasm, Breast
• Neoplasm of Lung
• Neoplasms,Colorectal
• Neoplasms Pancreatic
• Malignant Glioma
• Malignancies
• Malignancies Multiple
• Bone Metastases
• Bone Neoplasm
• Bone Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Breast Neoplasms
• Acute T Cell Leukemia Lymphoma

Interventions

DRUG

9-ING-41

Starting dose of-9-ING-41 will be administered on Day 1 and 4 each week of a 21-day cycle. 9-ING-41 will be administered intravenously over 60 minutes.

DRUG

Gemcitabine - 21 day cycle

Gemcitabine 1250 mg/m2 as a 30-minute intravenous infusion on Days 1 and 8 of a 21-day cycle

DRUG

Doxorubicin.

Doxorubicin 75 mg/m2, intravenous bolus on Day 1 of a 21-day cycle up to a maximum lifetime dose of 550 mg/m2.

DRUG

Lomustine

Lomustine 30 mg/m² orally as a single dose, weekly for twelve weeks.

DRUG

Carboplatin.

Carboplatin AUC 6 IV over 1 hour on Day 1 of a 21-day cycle.

DRUG

Nab paclitaxel.

Nab-paclitaxel 125 mg/m2 intravenously on Days 1, 8 and 15 of a 28-day cycle

DRUG

Paclitaxel.

Paclitaxel 175 mg/m2 intravenously over 3 hours on Day 1 of a 21-day cycle.

DRUG

Gemcitabine - 28 day cycle

Gemcitabine 1000 mg/m2 intravenously over 30-minutes on Days 1, 8 and 15 of a 28-day cycle

DRUG

Irinotecan

Irinotecan 350 mg/m2 intravenously over 90-minutes on Day 1 of a 21-day cycle

Sponsors & Collaborators

• Actuate Therapeutics Inc.

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-04

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States
• Belgium
• Canada
• France
• Netherlands
• Portugal
• Spain

Study Locations