9-ING-41 in Patients With Advanced Cancers

Running, not enrolling · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03678883

Run by

Actuate Therapeutics Inc.

People needed

350

Starts

2019-01-04

Expected to finish

2026-06-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Is aged ≥ 18 years
• Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:
• Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
• Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
• Malignancy has relapsed after standard therapy
• Malignancy for which there is no standard therapy that improves survival by at least 3 months
• Has evaluable tumor(s) by standard radiological and/or laboratory assessments as applicable to their malignancy - in Part 3, patients with solid tumors must have least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 criteria, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI). In the case of patients with glioblastoma multiforme (GBM) or other central nervous system (CNS) tumors, the tumor must be measurable, defined as a clearly enhancing tumor with at two perpendicular diameters at entry equal or superior to 1cm.
• Has laboratory function within specified parameters (may be repeated):
• Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 50,000/mL
• Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 3 (≤ 5 X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells) x ULN; bilirubin ≤ 1.5 x ULN
• Adequate renal function: creatinine clearance ≥ 60 mL/min (Cockcroft and Gault)
• Adequate blood coagulation: international normalized ratio (INR) ≤ 2.3
• Serum amylase and lipase ≤ 1.5 x ULN
• Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG) PS 0-2
• Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug (unless in the opinion of the investigator and the study medical coordinator the treatments/ procedures will not compromise patient safety or interfere with study conduct and with IDMC agreement):
• Chemotherapy, immunotherapy, or systemic radiation therapy - 14 days or ≥ 5 half-lives (whichever is shorter)
• Focal radiation therapy - 7 days
• Systemic and topical corticosteroids - 7 days
• Surgery with general anesthesia - 7 days
• Surgery with local anesthesia - 3 days
• May continue endocrine therapies (e.g. for breast or prostate cancer) and/or anti-human epidermal growth factor (Her2) therapies while on this study
• Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first study therapy. Women may be neither breastfeeding nor intending to become pregnant during study participation and must agree to use effective contraceptive methods (hormonal or barrier method of birth control, or true abstinence) for the duration of study participation and in the following 90 days after discontinuation of study treatment
• Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 90 days after discontinuation of study treatment and use appropriate barrier contraception or true abstinence

You may not qualify if…

• Patient -
• Is pregnant or lactating
• Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation
• Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as ≤ Grade 2 CTCAE Version 4.03
• Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of 9-ING-41, or cardiac arrhythmia requiring medical treatment detected at screening
• Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41 or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator or study medical coordinator
• Has known symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Patients with stable asymptomatic brain metastases or leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
• Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g. a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major)
• Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation
• Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another interventional clinical trial
• Has a current active malignancy other than the target cancer
• Is considered to be a member of a vulnerable population (for example, prisoners)
• Part 3 ARMB Inclusion Criteria: 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
• Is aged ≥ 18 years
• Has pathologically confirmed metastatic pancreatic cancer AND is previously untreated with systemic agents in the recurrence/metastatic setting.
• Must have at least 1 measurable lesion per RECIST v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI)
• Has laboratory function within specified parameters (may be repeated):
• e. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 75,000/mL f. Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 3 (≤ 10 X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells) x ULN; bilirubin ≤ 1.5 x ULN Adequate renal function: creatinine clearance ≥ 30 mL/min (Cockcroft and Gault)
• Has Eastern Co-operative Oncology Group (ECOG) PS 0 or 1
• Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug:
• Focal radiation therapy - 7 days
• Surgery with general anesthesia - 7 days
• Surgery with local anesthesia - 3 days
• May have received treatment with fluorouracil or gemcitabine as a radiation sensitizer in the adjuvant setting if the treatment was received at least 6 months before study enrollment

Where it is running

• Arizona Oncology Associates — Tucson, Arizona, United States
• The University of Arizona Cancer Center — Tucson, Arizona, United States
• University of California Irvine Health — Orange, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Christiana Care Health Services — Newark, Delaware, United States
• Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists - South — Fort Myers, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Florida Cancer Specialists - North — St. Petersburg, Florida, United States
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States
• Des Moines Oncology Research Association — Des Moines, Iowa, United States
• Kansas University Cancer Center — Kansas City, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Michigan — Ann Arbor, Michigan, United States
• MetroMetro-Minnesota Community Oncology Research Consortium (MMCORC) — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Capital Health Medical Center/ Hopewell — Pennington, New Jersey, United States
• MD Anderson Cancer Center at Cooper — Voorhees Township, New Jersey, United States
• Columbia University- Irving Medical Center — New York, New York, United States
• Stony Brook University Hospital — Stony Brook, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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