A clinical trial of a new drug known as 9-ING-41, that will take place inpatients with tumors or cancers that affect the blood and lymph system.9-ING-41 will be assessed as a standalone drug as well as being assessedwhen taken with chemotherapy drugs

Phase 1

• Conditions: Refractory Hematologic Malignancies or Solid Tumors; MedDRA version: 21.1Level: PTClassification code 10066476Term: Haematological malignancySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003739-32-NL
• Lead Sponsor: Actuate Therapeutics Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-30
• Last Update Posted: 2 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

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:
a. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
b. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
c. Malignancy has relapsed after standard therapy
d. 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 at 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 Part 3, 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 least two perpendicular diameters at entry equal or superior to 1cm. Patients with GBM will have progression after chemoradiotherapy with or without antiangiogenic treatment at least 3 months after the end of radiotherapy. Radiotherapy at a dose of no more than 65 Gy with stereotactic radiosurgery or brachytherapy is allowable if recurrence was histologically proven.
5. Has laboratory function within specified parameters (may be
repeated):
a. Adequate bone marrow function: absolute neutrophil count (ANC) = 500/mL; hemoglobin = 8.5 g/dL, platelets = 50,000/mL
b. Adequate liver function: transaminases (aspartate
aminotransferase/alanine aminotransferase, AST/ALT) and alkaline phosphatase = 3 (= 10X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells) x ULN; bilirubin = 1.5 x ULN
c. Adequate renal function: creatinine clearance = 60 mL/min (Cockcroft and Gault)
d. Adequate blood coagulation: international normalized ratio (INR) =2.3
e. 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:
• 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

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 not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and infertility. Recovery is defined as
= Grade 1 severity per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (v 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 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
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 malignancy other than the target cancer
11. Is considered to be a member of a vulnerable population (for example, prisoners)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified