Pancreatic cancer drug trial halted after safety issues
NCT ID NCT05525286
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tested a new drug called SOT102, alone or with standard chemotherapy, in 31 people with advanced pancreatic cancer. The goal was to find the safest dose and see if it helped shrink tumors. The study was stopped early because of unexpected safety problems that reappeared even after changes were made.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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31 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: All Parts (key criteria) * Hematologic: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥9 g/dL * Hepatic: Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN * Renal: Creatinine clearance ≥60 mL/min calculated by Cockcroft-Gault formula * Prothrombin time/international normalized ratio (INR) ≤1.5×ULN * Albumin ≥3.0 mg/dL * Proteinuria \<1 g/24 hours * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Estimated life expectancy ≥3 months as per investigator's assessment * A female patient is eligible to participate if she is not pregnant, not breastfeeding, not of childbearing potential/ agreed with contraception Part A * Patient has advanced inoperable or metastatic disease * Patient has no better treatment option available * Measurable or non-measurable disease according to RECIST 1.1 * Histological or cytological evidence of adenocarcinoma of pancreas that is advanced or metastatic Part B (in addition to relevant A criteria)\*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced or metastatic (pancreas) Part C (in addition to relevant A criteria)\*Must have received at least one prior systemic therapy for advanced or metastatic disease (pancreas) Part D (in addition to relevant B criteria)\*Histological or cytological evidence of adenocarcinoma of the pancreas that is advanced inoperable or metastatic (pancreas) Exclusion Criteria: All Parts (key criteria) * Patient has received radiation therapy ≤14 days before day 1 of cycle 1 or has not recovered to grade ≤1 from treatment-related side effects * Severe preexisting medical conditions as per judgement of the investigator (e.g., active gastric or GEJ ulcer with or without bleeding, complete or incomplete gastric outlet syndrome with persistent or repetitive bleeding) * History of interstitial pneumonitis or pulmonary fibrosis * Symptomatic central nervous system malignancy. Patients with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days. * Patient has peripheral sensory neuropathy grade ≥2 * Active infection requiring systemic therapy within ≤7 days prior to day 1 of cycle 1 * History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes) * Bradycardia (\<50 beats per minute) * Family history of sudden cardiac death before age 50 * History or family history of congenital long QT syndrome * Major surgical intervention ≤28 days prior to ICF signature or incomplete wound healing after surgical intervention * Time since last transfusion of RBCs ≤14 days before cycle 1 day 1 * Vaccination with a live or live-attenuated vaccine within 30 days prior the first dose of trial interventions Part B/D (key) \*Patients with contraindications to any component of the first-line SoC treatment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cleveland Clinic Main Campus
Cleveland, Ohio, 44195, United States
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Hospital Universitario HM Sanchinarro
Madrid, Spain
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Institut Gustave Roussy
Paris, France
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Institut Jules Bordet
Brussels, Belgium
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Masarykův Onkologický Ústav
Brno, Czechia
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Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium
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VHIO - Vall d'Hebron Institut d'Oncologia
Barcelona, Spain
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Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
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