Study on SOT102 for Patients with Advanced Gastric and Pancreatic Cancer, Alone or with Drug Combination

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What is this study about?

This clinical trial is focused on studying the treatment of two types of cancer: gastric adenocarcinoma, which affects the stomach, and pancreatic adenocarcinoma, which affects the pancreas. The trial will evaluate a new treatment called SOT102, which is an antibody drug conjugate. This means it is a special type of medicine designed to target cancer cells more precisely. The study will test SOT102 both on its own and in combination with other standard cancer treatments. These standard treatments include Folinic Acid, Abraxane, Oxaliplatin, Fluorouracil, Gemcitabine, and OPDIVO.

The purpose of the study is to find out how safe and effective SOT102 is for patients with advanced stages of these cancers. The study will be conducted in several parts. Initially, it will determine the best dose of SOT102 that can be given safely. Later, it will assess how well the treatment works in shrinking or controlling the cancer. Patients will receive the treatment through an intravenous infusion, which means the medicine will be given directly into a vein.

Throughout the study, participants will be closely monitored for any side effects and to see how their cancer responds to the treatment. The trial aims to provide valuable information on whether SOT102 can be a beneficial treatment option for people with these types of cancer. The study is expected to continue until early 2026, with the hope of improving treatment options for patients with gastric and pancreatic adenocarcinoma.

1 joining the trial

Upon joining the trial, you will be required to provide written informed consent. This is a document that confirms your understanding of the trial and your agreement to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This may include a review of your medical history, a physical examination, and various tests to ensure you meet the trial’s criteria.

3 treatment phase

During the treatment phase, you will receive the trial medication SOT102 either as a standalone treatment or in combination with standard care treatments. The medication is administered through an intravenous infusion, which means it is given directly into your vein.

The dosage and frequency of SOT102 will be determined based on the trial’s objectives to find the most effective and safe dose. You may also receive other medications such as folinic acid, paclitaxel albumin-bound, oxaliplatin, nivolumab, fluorouracil, and gemcitabine as part of the standard care treatment.

4 monitoring and follow-up

Throughout the trial, regular monitoring will be conducted to assess your response to the treatment and to check for any side effects. This may involve blood tests, imaging studies, and other assessments.

You will be required to attend scheduled visits to the trial site for these evaluations. The frequency of these visits will be determined by the trial protocol.

5 end of treatment

At the end of the treatment phase, a final assessment will be conducted to evaluate the overall effects of the treatment on your condition.

You may be asked to continue attending follow-up visits to monitor your health and any long-term effects of the treatment.

Who Can Join the Study?

Must be at least 18 years old.
Must have a type of cancer called gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ), or pancreatic adenocarcinoma.
Must have advanced inoperable or metastatic disease, meaning the cancer cannot be removed by surgery or has spread to other parts of the body.
Must provide a written informed consent before any trial-specific procedures. This means you agree to participate after being informed about the trial.
Must have at least one measurable lesion according to specific medical guidelines (RECIST 1.1). A lesion is an area of abnormal tissue.
Must have adequate tumor tissue or a sample from a previous biopsy available, or be willing to undergo a new biopsy.
Must have HER2-negative tumors if you have gastric/GEJ adenocarcinoma. HER2 is a protein that can affect the growth of cancer cells.
Must have received at least two prior treatments for advanced or metastatic gastric/GEJ adenocarcinoma, including anti-HER2 therapy if applicable.
Must have received at least one prior treatment for advanced or metastatic pancreatic adenocarcinoma, including anti-HER2 therapy if applicable.
Must have adequate organ function, which will be assessed by various medical tests.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures your ability to perform daily activities.
Must have an estimated life expectancy of at least 3 months according to the investigator’s assessment.
Female participants must not be pregnant or breastfeeding and must agree to use effective birth control if they are of childbearing potential.
Male participants must agree to use a condom during treatment and for 9 months after treatment ends. If planning to father a child, consider sperm preservation.
Must have a left ventricular ejection fraction (LVEF) of at least 50%, which is a measure of heart function.
Must have a QTcF interval of less than 450 milliseconds on an electrocardiogram (ECG), which measures heart rhythm.
Must not participate in other clinical trials while enrolled in this trial, except during the survival follow-up period.

Who Cannot Join the Study?

Patients with any other type of cancer besides gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction (GEJ) and pancreatic adenocarcinoma cannot participate.
Patients who have experienced severe side effects from previous cancer treatments may not be eligible.
Patients who are currently participating in another clinical trial are excluded.
Patients with serious uncontrolled medical conditions, such as heart disease or infections, cannot join the study.
Pregnant or breastfeeding women are not allowed to participate.
Patients who have had a major surgery within the last 4 weeks are excluded.
Patients with known allergies to the study medication or its ingredients cannot participate.
Patients with a history of drug or alcohol abuse may be excluded.
Patients who are unable to comply with the study procedures and follow-up visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Masarykuv Onkologicky Ustav	Brno-Stred	Czechia
Hpkddamw Vfnv dagtkfee	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.03.2022
Czechia	Not recruiting	31.03.2022
France	Not recruiting	31.03.2022
Spain	Not recruiting	31.03.2022

Trial locations

Investigated drugs:

SOT102 is a new medication being tested in this clinical trial. It is being studied to see how safe and effective it is for treating certain types of cancer, specifically gastric and pancreatic adenocarcinoma. The trial is looking at how well SOT102 works on its own and when used together with standard treatments that are already used for these cancers. The goal is to find the best dose that patients can tolerate without too many side effects and to see how well it helps in treating the cancer.

Gastric Adenocarcinoma – Gastric adenocarcinoma is a type of cancer that originates in the glandular cells of the stomach lining. It typically begins in the innermost layer of the stomach and can gradually invade deeper layers. As the disease progresses, it may spread to nearby lymph nodes and other organs. The growth of the tumor can lead to symptoms such as difficulty swallowing, weight loss, and abdominal pain. Over time, the cancer may metastasize to distant parts of the body. The progression can vary significantly among individuals.

Adenocarcinoma of the Gastroesophageal Junction – This cancer occurs where the esophagus meets the stomach, known as the gastroesophageal junction. It starts in the glandular cells that produce mucus and other fluids. The disease can progress by invading surrounding tissues and spreading to nearby lymph nodes. Symptoms may include difficulty swallowing, chest pain, and unintentional weight loss. As it advances, it can metastasize to distant organs. The rate of progression can differ from person to person.

Pancreatic Adenocarcinoma – Pancreatic adenocarcinoma is a cancer that begins in the cells lining the ducts of the pancreas. It often grows silently and may not cause symptoms until it is advanced. The disease can spread to nearby organs, lymph nodes, and eventually distant sites. Common symptoms include jaundice, abdominal pain, and weight loss. The tumor can obstruct the bile duct, leading to digestive issues. The progression of the disease can vary widely among patients.

Trial ID:

2023-504441-31-00

Protocol code:

SN201(CLAUDIO-01)

NCT ID:

NCT05525286

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on SOT102 for Patients with Advanced Gastric and Pancreatic Cancer, Alone or with Drug Combination

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