New drug shows promise for stubborn cancers

NCT ID NCT03678883

Disease control Sponsor: Actuate Therapeutics Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called 9-ING-41, given alone or with chemotherapy, in adults with cancers that have not responded to standard treatments. The goal is to see if the drug is safe and can help control the disease. About 350 people with various advanced cancers, including pancreatic, breast, and lung cancers, are taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient - 1. 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. 2. Is aged ≥ 18 years 3. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following: 1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition 2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit 3. Malignancy has relapsed after standard therapy 4. Malignancy for which there is no standard therapy that improves survival by at least 3 months 4. 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. 5. Has laboratory function within specified parameters (may be repeated): 1. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 50,000/mL 2. 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 3. Adequate renal function: creatinine clearance ≥ 60 mL/min (Cockcroft and Gault) 4. Adequate blood coagulation: international normalized ratio (INR) ≤ 2.3 5. Serum amylase and lipase ≤ 1.5 x ULN 6. Has adequate performance status (PS): Eastern Co-operative Oncology Group (ECOG) PS 0-2 7. 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 8. May continue endocrine therapies (e.g. for breast or prostate cancer) and/or anti-human epidermal growth factor (Her2) therapies while on this study 9. 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 10. 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 11. Must not be receiving any other investigational medicinal product Exclusion Criteria: * Patient - 1. Is pregnant or lactating 2. Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation 3. 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 4. 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 5. 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 6. 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 7. 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) 8. Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation 9. 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 10. Has a current active malignancy other than the target cancer 11. Is considered to be a member of a vulnerable population (for example, prisoners) Part 3 ARMB Inclusion Criteria: Patient - 1. 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 2. Is aged ≥ 18 years 3. Has pathologically confirmed metastatic pancreatic cancer AND is previously untreated with systemic agents in the recurrence/metastatic setting. 4. Must have at least 1 measurable lesion per RECIST v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI) 5. 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) 6. Has Eastern Co-operative Oncology Group (ECOG) PS 0 or 1 7. 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 8. 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 9. May have received neoadjuvant chemotherapy with FOLFIRINOX if last dose given at least 6 months before study enrollment 10. May have received prior cytotoxic doses of systemic chemotherapy in the adjuvant setting if last dose given at least 6 months before study enrollment 11. 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 12. 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 13. Must not be receiving any other investigational medicinal product Patient who meets ANY of the following criteria is not eligible for this Part 3 study Arm B: Exclusion Criteria: 1. Is pregnant or lactating 2. Is known to be hypersensitive to any of the components of 9-ING-41 or to the excipients used in its formulation 3. Has endocrine or acinar pancreatic carcinoma 4. Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and/or infertility. Recovery is defined as ≤ Grade 2 severity per CTCAE, v5.0 5. 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 study therapy, or uncontrolled cardiac arrhythmia 6. Has had a myocardial infarction within 12 weeks of the first dose of study therapy or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator 7. Has symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Patients with stable 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 8. 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) 9. Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation. 10. 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. 11. Has a current active malignancy other than pancreatic cancer 12. Is considered to be a member of a vulnerable population (for example, prisoners).

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Conditions

The condition(s) this trial relates to.

bone cancer bone neoplasm breast neoplasm cancer colorectal neoplasm glioma hereditary sensory and autonomic neuropathy kidney cancer Leukemia-Lymphoma, Adult T-Cell lung neoplasm malignant glioma malignant pancreatic neoplasm metastatic carcinoma in the bone metastatic neoplasm neoplasm Neoplasm Metastasis non-Hodgkin lymphoma pancreatic adenocarcinoma pancreatic neoplasm refractory hematologic cancer refractory malignant neoplasm renal carcinoma sarcoma T-cell acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute T cell leukemia lymphoma Bone cancer Bone metastases Bone neoplasm Breast neoplasms Cancer Malignancies Malignancies multiple Malignant glioma Neoplasm metastasis Neoplasm of bone Neoplasm of lung Neoplasm, breast Neoplasms, colorectal Neoplasms, pancreatic Pancreas cancer Pancreatic adenocarcinoma Pancreatic cancer Pancreatic neoplasms Refractory cancer Refractory neoplasm Refractory non-Hodgkin lymphoma Renal cancer Resistant cancer Sarcoma

Contacts and locations

Locations

Allegheny Health Network

Pittsburgh, Pennsylvania, 15212, United States
Arizona Oncology Associates

Tucson, Arizona, 85704, United States
Baptist Clinical Research Institute

Memphis, Tennessee, 38120, United States
CHRU Brest Hopital Morvan

Brest, Brittany Region, 29200, France
Capital Health Medical Center/ Hopewell

Pennington, New Jersey, 08534, United States
Center Hospitalier Regional Universitaire de Besancon - Site Jean Minjoz

Besançon, Bourgogne-Franche-Comté, 25030, France
Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre

Greenfield Park, Quebec, G4V 2H1, Canada
Centro Hospitalar Universitario Sao Joao

Porto, 4200-319, Portugal
Christiana Care Health Services

Newark, Delaware, 19709, United States
Columbia University- Irving Medical Center

New York, New York, 10032, United States
Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89128, United States
Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada
Des Moines Oncology Research Association

Des Moines, Iowa, 50309, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Florida Cancer Specialists - North

St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - South

Fort Myers, Florida, 33901, United States
Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States
Fundacao Champalimaud

Lisbon, 1400-038, Portugal
Hopital Claude Huriez

Lille, Hauts-de-France, 59037, France
Hopital de la Timone

Marseille, 13005, France
Hospital Clinico U San Carlos (HSC)

Madrid, 28050, Spain
Hospital Da Luz

Lisbon, 1500-650, Portugal
INCLIVA University of Valencia

Valencia, 46010, Spain
Imelda VZW

Bonheiden, 2820, Belgium
Insitut de Cancerologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, 44800, France
Institut Bergonie

Bordeaux, New Aquitaine, 33076, France
Institut Catala d'Oncologia

Barcelona, 8908, Spain
Institute de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France
Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada
Kansas University Cancer Center

Kansas City, Kansas, 66160, United States
MD Anderson Cancer Center at Cooper

Voorhees Township, New Jersey, 08043, United States
Mayo Clinic

Phoenix, Arizona, 85054, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada
MetroMetro-Minnesota Community Oncology Research Consortium (MMCORC)

Minneapolis, Minnesota, 55416, United States
Miami Cancer Institute

Miami, Florida, 33176, United States
Morristown Medical Center

Morristown, New Jersey, 07960, United States
Netherlands Cancer Institute

Amsterdam, 1066 CX, Netherlands
Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Prisma Health Cancer Institute

Greenville, South Carolina, 26905, United States
QE II Health Sciences Centre

Halifax, Nova Scotia, B3H 2Y9, Canada
Rhode Island Hospital

Providence, Rhode Island, 02903, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, 60611, United States
START Madrid-HM CIOCC Hospital Universitario

Madrid, 28050, Spain
Sanford Research

Sioux Falls, South Dakota, 57105, United States
Sarah Cannon Research Institute- Tennessee Oncology-Nashville

Nashville, Tennessee, 37203, United States
Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States
St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States
Stony Brook University Hospital

Stony Brook, New York, 11794, United States
Texas Oncology- Charles A. Sammons Cancer Center

Dallas, Texas, 75246, United States
The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States
UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States
UT Southwestern Medical Center

Dallas, Texas, 75390, United States
UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States
UZ Gent

Ghent, 9000, Belgium
UZ Leuven Gasthuisberg

Leuven, 3000, Belgium
UZA- Antwerpen

Edegem, Antwerp, 2650, Belgium
University of California Irvine Health

Orange, California, 92868, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
Utah Cancer Specialists

Salt Lake City, Utah, 84124, United States
Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain
Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States
West Cancer Center

Germantown, Tennessee, 38138, United States
West Virginia University

Morgantown, West Virginia, 26506, United States

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