ELRAGLUSIB for Haematological malignancy | Solid tumor | Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- 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\n- 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 highly effective contraceptive methods (refer to section 4.1.1 for specific definitions of highly effective methods of contraception) for the duration of study participation and in the following 6 months after discontinuation of study treatment\n- Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 6 months after discontinuation of study treatment and use appropriate methods of contraception\n- Must not be receiving any other investigational medicinal product\n- Is aged ≥ 18 years\n- Has pathologically or cytologically confirmed metastatic pancreatic cancer AND is previously untreated with systemic agents in the recurrence/metastatic setting AND would be a candidate to receive gemcitabine/nab-paclitaxel as a first-line treatment\n- Must have at least 1 measurable lesion per RECIST v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI)\n- Has laboratory function within specified parameters (may be repeated): a.\tAdequate bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100,000/mL b.\tAdequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 5 x the upper limit of normal (ULN); bilirubin ≤ 1.5 x ULN c.\tAdequate renal function: serum creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min for patients with a serum creatinine >ULN (calculated by the Cockcroft and Gault formula)\n- Has Eastern Co-operative Oncology Group (ECOG) PS 0 or 1\n- Has received the final dose of any of the following treatments/ procedures with the specified minimum intervals before first dose of study drug: •\tFocal radiation therapy – 7 days •\tSurgery with general anesthesia – 7 days •\tSurgery with local anesthesia – 3 days\n- 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\n- Puede haber recibido previamente dosis citotóxicas de quimioterapia sistémica como parte de un tratamiento neoadyuvante y/o adyuvante si las últimas dosis se han administrado al menos 6 meses antes del reclutamiento del estudio"}

Exclusion criteria

• {"criterion_text":"- Is pregnant or lactating\n- 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.\n- Has a current active malignancy other than pancreatic cancer\n- Is considered to be a member of a vulnerable population (for example, prisoners).\n- Is known to be hypersensitive to any of the components of Elraglusib or to the excipients used in its formulation\n- Has endocrine or acinar pancreatic carcinoma\n- 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\n- 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\n- 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\n- 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\n- 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 consideredmajor)\n- Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation."}

Primary endpoints

• {"endpoint_text":"- 1-year survival rate of patients treated on the Elraglusib schedule chosen from the run-in portion of the study compared to the control arm.","definition_or_measurement_approach":"1-year survival rate compared between patients receiving the selected elraglusib schedule (from run-in) and the control arm; measured as the proportion of patients alive at 1 year."}

Secondary endpoints

• {"endpoint_text":"- Disease control rate (DCR), defined as: Stable disease for ≥16 weeks, confirmed complete response, or confirmed partial response.","definition_or_measurement_approach":"DCR defined as stable disease ≥16 weeks, or confirmed complete response (CR), or confirmed partial response (PR)."}
• {"endpoint_text":"- Objective response rate (ORR), defined as the percent of patients with Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria relative to the efficacy population.","definition_or_measurement_approach":"ORR = percentage of patients with CR or PR per RECIST v1.1 in the efficacy population."}
• {"endpoint_text":"- Duration of Response (DOR), defined as the time from documentation of tumor response to disease progression","definition_or_measurement_approach":"DOR measured as time from documentation of tumor response to documented disease progression."}
• {"endpoint_text":"- Progression-Free Survival (PFS), defined as the time from study enrolment until objective tumor progression or death","definition_or_measurement_approach":"PFS measured as time from study enrolment to objective tumor progression or death."}
• {"endpoint_text":"- OS, defined as the time from study entry to death from any cause","definition_or_measurement_approach":"Overall survival measured as time from study entry to death from any cause."}
• {"endpoint_text":"- Time to Treatment Failure (TTF)","definition_or_measurement_approach":"TTF measured as time from treatment start to discontinuation due to progression, toxicity, death, or other treatment failure."}
• {"endpoint_text":"- Adverse events will be monitored from the date of first administration of Elraglusib and ending 30 days after the final administration of Elraglusib using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0","definition_or_measurement_approach":"Safety monitoring of adverse events from first Elraglusib administration until 30 days after last administration, graded per CTCAE v5.0."}
• {"endpoint_text":"- Correlation of disease control rate with tumor molecular profiles","definition_or_measurement_approach":"Exploratory correlation analyses between DCR and tumor molecular profile data (molecular profiling methods as per protocol)."}

France

Earliest CTIS Part Ii Submission Date

31-10-2024

Latest Decision Or Authorization Date

19-08-2025

Processing Time Days

292

Number Of Sites

3

Number Of Participants

80

Spain

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

19-08-2025

Processing Time Days

305

Number Of Sites

2

Number Of Participants

65

Portugal

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

19-08-2025

Processing Time Days

305

Number Of Sites

1

Number Of Participants

40

Belgium

Earliest CTIS Part Ii Submission Date

18-10-2024

Latest Decision Or Authorization Date

18-08-2025

Processing Time Days

304

Number Of Sites

3

Number Of Participants

40

Primary sponsor

Full Name

Actuate Therapeutics Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

Ireland

Contract research organisations

Name

EDC Easy

Responsibilities

codes: 6,7

Name

Bioagilytix Labs LLC

Responsibilities

codes: 4

Name

Tempus Compass LLC

Responsibilities

codes: 4

Name

Harvest Integrated Research Organization

Responsibilities

codes: 1,12,2

Name

Mosaic Laboratories LLC

Responsibilities

codes: 4

Name

Oncology Therapeutic Development

Responsibilities

codes: 1,12,2

Name

Propharma Group The Netherlands B.V.

Responsibilities

codes: 8

Name

Sirius Regulatory Consulting EU Limited

Responsibilities

codes: 12

Third parties

• {"country":"United States","full_name":"EDC Easy","duties_or_roles":"codes: 6,7","organisation_type":"Industry"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Tempus Compass LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Harvest Integrated Research Organization","duties_or_roles":"codes: 1,12,2","organisation_type":"Industry"}
• {"country":"United States","full_name":"Mosaic Laboratories LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Oncology Therapeutic Development","duties_or_roles":"codes: 1,12,2","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"Propharma Group The Netherlands B.V.","duties_or_roles":"codes: 8","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Sirius Regulatory Consulting EU Limited","duties_or_roles":"codes: 12","organisation_type":"Pharmaceutical company"}