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Pancreatic cancer drug trial halted after safety issues

NCT ID NCT05525286

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

31 people

The number who actually took part.

Started

Mar 2022

Finished

Dec 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195, United States

  • Hospital Universitario HM Sanchinarro

    Madrid, Spain

  • Institut Gustave Roussy

    Paris, France

  • Institut Jules Bordet

    Brussels, Belgium

  • Masarykův Onkologický Ústav

    Brno, Czechia

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Belgium

  • VHIO - Vall d'Hebron Institut d'Oncologia

    Barcelona, Spain

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

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