Advanced cancer treatment with elraglusib

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    What is this study about?

    This study is about testing a new drug called elraglusib (9-ING-41) on people who have aggressive types of cancers that have not responded to other treatments to fight it. elraglusib is a new type of drug that could help in blocking a specific cancer growth pathway, used alone or with chemotherapy. This research trial aims to see if elraglusib is both safe and effective when used alone or together with common chemotherapy drugs. This research hopes to offer a promising new treatment option for patients facing challenging cancer types.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      Here are the key steps a patient would likely go through in this clinical trial, based on the provided information:

      1. Screening and Enrollment
        • Patient is determined to meet eligibility criteria, such as having a confirmed advanced or metastatic cancer that is refractory to standard therapies
        • Patient signs informed consent form
        • Baseline tumor assessments and laboratory tests are performed
      2. Treatment
        • 9-ING-41 is administered intravenously on Day 1 and 4 of each week in 21-day cycles, either alone or in combination with another chemotherapy drug, depending on the treatment arm patient is assigned to
        • Potential chemotherapy drug combinations with 9-ING-41 include:
          • Gemcitabine on Days 1 and 8 of 21-day cycles
          • Doxorubicin on Day 1 of 21-day cycles
          • Lomustine orally weekly for 12 weeks
          • Carboplatin on Day 1 of 21-day cycles
          • Nab-paclitaxel on Days 1, 8, 15 of 28-day cycles with gemcitabine
          • Paclitaxel and carboplatin on Day 1 of 21-day cycles
          • Irinotecan on Day 1 of 21-day cycles
        • Treatment continues until unacceptable toxicity, disease progression, or other discontinuation criteria
      3. Follow-up
        • Tumor assessments, lab tests and evaluation of adverse events are performed regularly to monitor safety and efficacy
        • Long-term follow-up for survival outcomes

      The timeline for an individual patient will depend on how long they tolerate treatment and derive clinical benefit, but could range from a few months up to a few years based on the estimated primary completion date of November 2024.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria, to join this study you would need to have one of the following diseases or cancers:

      • Advanced or metastatic cancer that is either:
        • Intolerant to existing therapies known to provide clinical benefit
        • Refractory to existing therapies known to potentially provide clinical benefit
        • Relapsed after standard therapy
        • Has no standard therapy available that improves survival by at least 3 months
      • For Part 3 Arm B specifically, you must have:
        • Pathologically confirmed metastatic pancreatic cancer that is previously untreated with systemic agents in the recurrent/metastatic setting

      The study includes patients with solid tumors and hematologic malignancies such as lymphoma, leukemia, breast cancer, pancreatic cancer, renal cancer, sarcoma, glioblastoma and others. But the key criteria is having an advanced cancer that has progressed despite standard treatments.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here is a list of the inclusion criteria with explanations of the medical terms:

      Inclusion Criteria:

      1. Informed Consent: Must be able to understand and voluntarily sign a written informed consent and be willing to comply with the protocol requirements (i.e., attend scheduled visits, follow the treatment plan, undergo laboratory tests, and other study procedures).
      2. Age Requirement: Must be at least 18 years old.
      3. Medical Condition:
        • Intolerant of existing therapies known to provide clinical benefit for their condition (not able to tolerate the side effects or not responding to current treatments).
        • Refractory disease: Malignancy that does not respond to existing therapy(ies) intended to provide clinical benefit.
        • Relapsed after standard therapy: The malignancy has returned after having initially responded to standard treatment.
        • Has a malignancy for which there is no standard therapy that improves survival by at least 3 months.
      4. Tumor Assessment:
        • Must have evaluable tumor(s) by standard radiological and/or laboratory assessments. For solid tumors, there must be at least 1 measurable lesion per RECIST v1.1 criteria.
        • For patients with glioblastoma multiforme (GBM) or other CNS tumors, the tumor must be measurable, meaning it is visibly enhancing on scans with two measurable perpendicular diameters equal to or greater than 1 cm.
      5. Laboratory Function:
        • Adequate bone marrow function: ANC ≥ 500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 50,000/mL.
        • Adequate liver function: AST/ALT and alkaline phosphatase ≤ 3 (≤ 5 times if liver metastasis is present) x ULN; bilirubin ≤ 1.5 x ULN.
        • Adequate renal function: Creatinine clearance ≥ 60 mL/min.
        • Adequate blood coagulation: INR ≤ 2.3.
        • Serum amylase and lipase ≤ 1.5 x ULN.
      6. Performance Status:
        • Has an ECOG performance status of 0-2, indicating the ability to carry out all self-care but unable to carry out any work activities up to being ambulatory and capable of all self-care but unable to carry out any work activities.
      7. Pre-treatment Waiting Periods:
        • Must have observed waiting periods after certain treatments before receiving the first dose of the study drug.
      8. May continue endocrine therapies (for example, hormone therapy for breast or prostate cancer) and/or anti-human epidermal growth factor (Her2) therapies while on this study.
      9. Reproductive Health:
        • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
        • Male patients with partners of childbearing potential must also use contraception to avoid fathering a child.
      10. Other Treatments:
        • Must not be receiving any other experimental medicines.

      Explanations of Medical Terms:

      RECIST v1.1 (Response Evaluation Criteria In Solid Tumors): A set of published rules that define when cancer patients improve (“respond”), stay the same (“stable”), or worsen (“progress”) during treatments.
      Creatinine clearance: A test that measures the efficiency of the kidneys in removing creatinine (a waste product) from the blood.
      INR (International Normalized Ratio): A calculation based on the prothrombin time test results used to monitor individuals who are being treated with the blood-thinning medication warfarin.
      ANC (Absolute Neutrophil Count): A measure of the number of neutrophil granulocytes (a type of white blood cell important for fighting off infections) present in the blood.
      AST (Aspartate Aminotransferase) / ALT (Alanine Aminotransferase): Enzymes found in liver cells that are released into the bloodstream when the liver is damaged.
      ECOG Performance Status: A scale used by doctors and researchers to assess how a patient’s disease is progressing, how the disease affects the daily living abilities of the patient, and how the disease impacts the prognosis for the patient.

      What Reasons Could Exclude Me from the Study?

      Based on the eligibility criteria, you cannot take part in this study if you meet any of the following exclusion criteria:

      General Exclusion Criteria:

      1. Pregnancy or breastfeeding – The study drugs may be unsafe for pregnant women or nursing infants.
      2. Known hypersensitivity to 9-ING-41 or its components – Having an allergy to the study drug or its ingredients would be dangerous.
      3. Unrecovered clinically significant toxicities from prior cancer therapy (except hair loss and infertility) – You must have healed from major side effects of previous treatments. Toxicities refer to harmful treatment effects.
      4. Significant cardiovascular issues: history of severe congestive heart failure, unstable angina, recent stroke, or uncontrolled abnormal heart rhythm – Serious pre-existing heart problems put you at higher risk of complications.
      5. Recent heart attack or abnormal electrocardiogram (ECG) deemed medically relevant – A weakened heart or concerning ECG results could make the treatment unsafe.
      6. Symptomatic rapidly progressing brain metastases or leptomeningeal involvement (cancer spread to brain or membranes covering brain and spinal cord) – Fast growing brain tumors require different management. Slow growing or stable brain tumors may be allowed.
      7. Recent major surgery or planned major surgery during the study – Time is needed to heal before starting a new treatment. Major surgery involves extensive operations like entering body cavities or removing organs.
      8. Medical or social condition that would interfere with study participation per investigator – The researchers determine if any issues would make it difficult for you to complete the study.
      9. Use of other investigational cancer drugs or current participation in another interventional trial – Combining investigational treatments or trials could be dangerous or compromise results. Prior treatments must have been stopped long enough ago.
      10. Active malignancy other than the cancer being treated in the study – Having a second untreated cancer is not allowed to avoid potential interactions or confusion in evaluating effects.
      11. Member of a vulnerable population like prisoners – Extra precautions are taken to protect people with reduced autonomy.

      Additional Exclusion Criteria for Part 3 Pancreatic Cancer Group:

      1. Rare pancreatic tumor types (endocrine or acinar) – The treatment is meant for the most common type of pancreatic cancer, adenocarcinoma.
      2. Prior systemic treatments for advanced pancreatic cancer – Testing 9-ING-41 as an initial treatment for metastatic disease, but prior adjuvant therapy (after surgery) or radiation is allowed if completed long enough ago.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The following drugs are involved in this clinical trial:

      • 9-ING-41: A potent, selective glycogen synthase kinase-3 beta (GSK-3β) inhibitor. It is the main investigational drug being studied as a single agent and in combination with various chemotherapy regimens.
      • Gemcitabine (Gemzar): A chemotherapy drug used to treat various types of cancer. In this study, gemcitabine is being evaluated in combination with 9-ING-41.
      • Doxorubicin (Adriamycin, Doxil): An anthracycline chemotherapy drug used to treat many types of cancer. Doxorubicin is being studied in combination with 9-ING-41.
      • Lomustine (CCNU, Gleostine): An alkylating chemotherapy agent used to treat brain tumors and other cancers. Lomustine is being evaluated in combination with 9-ING-41.
      • Carboplatin (Paraplatin): A platinum-based chemotherapy drug used to treat various types of cancer. Carboplatin is being studied in combination with 9-ING-41, as well as with paclitaxel and 9-ING-41.
      • Nab-paclitaxel (Abraxane, protein-bound paclitaxel): A nanoparticle albumin-bound formulation of the chemotherapy drug paclitaxel. Nab-paclitaxel is being evaluated in combination with gemcitabine and 9-ING-41.
      • Paclitaxel (Taxol): A chemotherapy drug used to treat various types of cancer. Paclitaxel is being studied in combination with carboplatin and 9-ING-41.
      • Irinotecan (Camptosar): A topoisomerase I inhibitor chemotherapy drug used to treat colorectal and other cancers. Irinotecan is being evaluated in combination with 9-ING-41.

      The main purpose of this study is to assess the safety and efficacy of 9-ING-41 as a single agent and in combination with various standard chemotherapy drugs in patients with advanced cancers. The chemotherapy drugs serve as established treatments for the specific cancer types, while 9-ING-41 is being investigated as a potential new therapy to improve treatment outcomes.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Yes, the active substances being investigated in this clinical trial are already known to medicine and used as cancer treatments. Here is a list of the substances with descriptions:

      • 9-ING-41: An investigational small molecule inhibitor of glycogen synthase kinase-3 beta (GSK-3β). 9-ING-41 is being evaluated as a potential new anticancer treatment, but is not an approved medicine at this time.
      • Gemcitabine: A chemotherapy drug used to treat various types of cancer, including pancreatic cancer, breast cancer, ovarian cancer, and lung cancer. It is an antimetabolite that disrupts DNA synthesis in cancer cells.
      • Doxorubicin: An anthracycline chemotherapy medication used to treat many cancers, including breast cancer, bladder cancer, lymphoma, and acute lymphocytic leukemia. It works by intercalating DNA and inhibiting topoisomerase II.
      • Lomustine: An oral alkylating chemotherapy drug used in the treatment of brain tumors as well as Hodgkin lymphoma and non-Hodgkin lymphoma. It crosslinks DNA to inhibit cancer cell growth.
      • Carboplatin: A platinum-based chemotherapy medication used to treat ovarian, lung, head and neck, endometrial, esophageal, bladder, breast, and cervical cancers. It crosslinks DNA to stop cancer cell division.
      • Nab-paclitaxel: An albumin-bound nanoparticle formulation of paclitaxel used to treat breast cancer, non-small cell lung cancer, and pancreatic cancer. Paclitaxel works by disrupting microtubule function to inhibit cell division.
      • Paclitaxel: A taxane chemotherapy drug used to treat breast, ovarian, lung, bladder, prostate, melanoma, esophageal and other types of solid tumor cancers. It stabilizes microtubules to prevent cancer cell division.
      • Irinotecan: A topoisomerase I inhibitor chemotherapy drug used to treat colon cancer and small cell lung cancer. It prevents DNA from unwinding and therefore inhibits cancer cell replication.

      In summary, except for the investigational agent 9-ING-41, all of the other active substances in this clinical trial are well-established FDA-approved chemotherapy medications that are mainstays in the treatment of various cancers. The trial is examining 9-ING-41 both alone and in combination with these standard chemotherapy agents.