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Actuate 1801: Elraglusib (9-ING-41) is an investigational study drug give alone or in combination with other chemotherapies, for the potential treatment of patients who have not been previously treated for pancreatic cancer that has spread to other parts of the body
EU CTIS ID: 2024-518409-16-00
What this study is testing
To determine the 1-year survival rate of patients treated on the elraglusib schedule chosen from the run-in stage of the study compared to the control arm.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- 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
- 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
- Must not be receiving any other investigational medicinal product
- Is aged ≥ 18 years
- 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
You likely can't join if
- Is pregnant or lactating
- 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 pancreatic cancer
- Is considered to be a member of a vulnerable population (for example, prisoners).
- Is known to be hypersensitive to any of the components of Elraglusib or to the excipients used in its formulation
- Has endocrine or acinar pancreatic carcinoma
See the full eligibility criteria
Who can join
- 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
- 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
- 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
- Must not be receiving any other investigational medicinal product
- Is aged ≥ 18 years
- 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
- 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): a. Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100,000/mL b. Adequate 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. Adequate 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)
- 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
- 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
What rules you out
- Is pregnant or lactating
- 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 pancreatic cancer
- Is considered to be a member of a vulnerable population (for example, prisoners).
- Is known to be hypersensitive to any of the components of Elraglusib or to the excipients used in its formulation
- Has endocrine or acinar pancreatic carcinoma
- 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
- 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
- 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
- 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
- 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)
- Has any medical and/or social condition which, in the opinion of the investigator or study medical coordinator would preclude study participation.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.