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

Starting soon · Early Phase 1

Conditions studied: Pancreatic Cancer, Colorectal Cancer, Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT07627191

Run by

University of Arizona

People needed

30

Starts

2026-07-10

Expected to finish

2028-06-30

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:

You may not qualify if…

• 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 months before the first dose of study treatment.
• Any of the following within 6 months before the first dose of study treatment:
• unstable angina pectoris;
• clinically-significant cardiac arrhythmias;
• stroke (including transient ischemic attack (TIA), or other ischemic event);
• myocardial infarction;
• GI disorders particularly those associated with a high risk of perforation or fistula formation including:
• Unresolved abdominal fistula, GI perforation, bowel obstruction, intra-abdominal abscess.
• Uncontrolled nausea, vomiting, or abdominal pain.
• Other clinically significant disorders that would preclude safe study participation
• Major surgery within 8 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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