AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer

RecruitingEARLY Phase 1Ages 18 Years - 99 YearsAllUniversity of Arizona
💬

In plain words

What the trial is, and whether it could suit you

There is a growing number of patients diagnosed with gastrointestinal cancers who are also simultaneously being treated with GLP-1 Receptor Agonists (RA)s. To date, no clinical trial data exists to establish safety and/or feasibility with use of GLP-1 RAs during chemotherapy in the metastatic setting. The goal of this clinical trial is to evaluate the safety, tolerability, preliminary efficacy, and correlative analyses of combining GLP-1 RAs with standard chemotherapy in patients with metastatic pancreatic, colorectal, or hepatocellular cancers in the first-line setting.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Histological or cytological diagnosis of pancreatic adenocarcinoma or colorectal adenocarcinoma. Previous tumor tissue testing is acceptable. Please refer to the "additional HCC cohort criteria" below. * The subject has disease that is not amenable to curative-intent management (e.g., oligometastatic disease) * Measurable disease per RECIST v1.1 as determined by the investigator * Patients must be appropriate candidates for first-line, SOC treatment. * SOC treatment as defined by NCCN® guidelines or institutional standard is allowable, however, options restricted to: * Colorectal: FOLFOX or FOLIFIRI +/- bevacizumab * Pancreatic: mFOLFIRINOX * HCC: Tremelimumab/Durvalumab * Patients are eligible who received prior perioperative chemotherapy for curative intent treatment and recurred ≥ 6 months since last dose of chemotherapy. * ≥ 18 years old on day of consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate archival frozen or fixed tissue available from primary or metastatic site for genotypic analysis (at least 15 unstained slides and/or tumor block) * Adequate hematologic and organ function laboratory values as follows: * The ANC ≥ 1500/mm3 without colony stimulating factor support; * Platelets ≥ 75,000/mm3; * Hemoglobin ≥ 9 g/dL; * Bilirubin ≤ 1.5 ´ the ULN. For subjects with known Gilbert's disease, bilirubin ≤ 3.0 mg/dL; * Serum albumin ≥ 2.8 g/dl; * ALT and AST ≤ 3.0 ´ ULN; * Serum creatinine ≤ 1.5 ´ ULN or creatinine clearance (CrCl) ≥ 40 mL/min. For creatinine clearance estimation, the Cockcroft and Gault equation should be used: * Male: CrCl (mL/min) = (140 - age) × wt (kg) / (serum creatinine × 72); * Female: Multiply above result by 0.85; * The subject is capable of understanding and complying with the protocol requirements and has signed the informed consent document * Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control or practice abstinence during the study and for 4 months after the last dose of study drug(s); Additional Inclusion Criteria for HCC Cohort ONLY: * Histologically or radiologically confirmed hepatocellular carcinoma (per AASLD/EASL criteria) * Unresectable or advanced HCC not amenable to curative surgery or locoregional therapy. * Barcelona Clinic Liver Cancer (BCLC) stage B or C. * Child-Pugh Score Class A; or Child-Pugh Class B7 or B8 at discretion of treating physician * Patients with HBV infection, characterized by positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU/mL or above the limit of detection per local or central lab standard), must be treated with antiviral therapy, as per institutional practice to ensure adequate viral suppression (HBV DNA \<2000 IU/mL) before enrolment. Patients must remain on antiviral therapy for the duration of their participation in the EAP and for 6 months after the last dose of EAP medication. Patients who test positive for anti-hepatitis B core (HBc) with undetectable HBV DNA (\<10 IU/mL or under the limit of detection per local or central lab standard) do not require anti-viral therapy before enrolment. These participants will be tested at every cycle to monitor HBV DNA levels and initiate anti-viral therapy if HBV DNA is detected (≥10 IU/mL or above the limit of detection per local or central lab standard). HBV DNA detectable patients must initiate and remain on anti-viral therapy for time they are on the EAP and for 6 months after the last dose of EAP medication. o Note: Testing required for subjects with a known history otherwise not required. * Patients with HCV infection must have confirmed diagnosis of HCV characterized by the presence of detectable HCV ribonucleic acid (RNA) or anti-HCV antibody upon enrolment (management of this disease is per local institutional practice). Exclusion Criteria * The subject has received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (eg, cytokines or antibodies) for metastatic and/or unresectable disease. * BMI \< 25 kg/m2 * For colorectal cancer only - Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) tumors. * For colorectal cancer only - BRAF V600E mutant tumors. * A personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). * A prior hypersensitivity reaction to semaglutide or any of the excipients in WEGOVY®. Serious hypersensitivity reaction, including anaphylaxis and angioedema, have been reported with WEGOVY®. * Cachexia * Subjects on insulin. * Subjects with a history of diabetic retinopathy * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment * The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: o Cardiovascular disorders including: * For patients being considered for bevacizumab (or bevacizumab biosimilar) only: * Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic or \> 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment; * thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (eg, vena cava filter) within 6 mon
💊

What it tests

  • GLP1-RA (semaglutide)
📍

Where

1 site
University of Arizona Cancer Center
Tucson, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy