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Sot102

Clinical trials are investigating Sot102 in people with advanced gastric, gastroesophageal junction (GEJ), and pancreatic adenocarcinoma. These studies aim to understand safety, dose selection, and how well Sot102 works alone or with first-line standard treatment. The trial includes adults with these cancers in a Phase 1/2 study.

Table of Contents

Trial overview

The main clinical trial in the source data is NCT05525286, also called CLAUDIO-01, which studied Sot102 in people with advanced gastric and pancreatic adenocarcinoma.[1]

This was an interventional study, which means the research team gave treatment and then measured the results.[1]

The trial was in Phase 1/2, so it first focused on dose and safety, then on early signs of benefit.[1]

Who was studied

The trial studied patients with advanced gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction (GEJ), and pancreatic adenocarcinoma.[1]

These are cancer types that start in gland-like cells, and the GEJ is the area where the esophagus meets the stomach.[1]

The study enrolled 298 people, showing that it was a fairly large early-phase cancer trial.[1]

What the study measured

In Parts A and B, the main goal was to find the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of Sot102.[1]

The MTD is the highest dose that can be tested without too many people having dose-limiting toxicity (DLT), which means side effects severe enough to limit treatment.[1]

The RP2D is the dose chosen for later studies after looking at the full clinical and preclinical data, which includes human study results and earlier laboratory work.[1]

In Parts C and D, the trial looked at objective response rate, which is the percentage of patients whose tumors shrink or disappear during treatment.[1]

Treatment groups and study design

Sot102 was tested as monotherapy, meaning by itself, and also in combination with first-line standard of care, which is the usual first treatment used for a disease.[1]

The source data lists several standard treatment drugs used in the study, including folinic acid, Abraxane, oxaliplatin, OPDIVO, gemcitabine, and fluorouracil.[1]

This design let researchers compare Sot102 alone with Sot102 plus standard treatment in different parts of the trial.[1]

Trial status and size

The trial status is Completed, so the study has finished collecting data.[1]

Because the study was completed and included 298 participants, it provided early information on both dose selection and tumor response in these cancer groups.[1]

Patient glossary

Monotherapy means one treatment is used alone, without another cancer drug added.[1]

Combination treatment means Sot102 was given together with other cancer medicines.[1]

Clinical trial phase is the stage of research, and Phase 1/2 usually means the study is checking both safety and early benefit.[1]

Enrollment is the number of people who joined the study.[1]

Objective response rate is a standard way to measure whether tumors got smaller during treatment.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05525286 Phase 1/2 Advanced gastric adenocarcinoma, GEJ adenocarcinoma, pancreatic adenocarcinoma Completed 298

FAQ

  • What is being studied in Sot102 clinical trials? The trials are studying Sot102 in people with advanced gastric, GEJ, and pancreatic adenocarcinoma. Researchers are looking at the right dose and whether the treatment helps shrink tumors.
  • Who can take part in these trials? The trial includes patients with advanced gastric adenocarcinoma, adenocarcinoma of the GEJ, or pancreatic adenocarcinoma. It is designed for people with these cancer types.
  • What phase is the Sot102 trial? This is a Phase 1/2 trial. Phase 1/2 studies usually look at dose, safety, and early signs of benefit.
  • What are the main goals of the study? The main goals are to find the maximum tolerated dose and the recommended phase 2 dose. The study also checks how well Sot102 works by measuring objective response rate.
  • Is Sot102 being tested alone or with other treatment? Sot102 is being tested both as a single treatment and together with first-line standard of care treatment. The study compares these approaches in different parts of the trial.

Ongoing Clinical Trials on Sot102

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

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Belgium Czechia France Spain

Glossary

  • Advanced cancer: Cancer that has spread or is no longer limited to one small area.
  • Adenocarcinoma: A cancer that starts in gland-like cells, which make mucus or other fluids.
  • Gastric adenocarcinoma: A type of stomach cancer that starts in gland-like cells.
  • Gastroesophageal junction (GEJ): The area where the esophagus meets the stomach.
  • Pancreatic adenocarcinoma: A common type of pancreatic cancer that starts in gland-like cells.
  • Phase 1/2: A study stage that first looks at safety and dose, then checks early signs of how well the treatment works.
  • Maximum tolerated dose (MTD): The highest dose that can be given before too many patients have serious dose-limiting side effects.
  • Recommended phase 2 dose (RP2D): The dose chosen for later studies based on safety and other study data.
  • Dose-limiting toxicity (DLT): A side effect serious enough to limit how much of a treatment can be given.
  • Objective response rate: The percentage of patients whose tumors shrink or disappear during treatment.
  • First-line standard of care: The usual treatment given first for a disease.
  • Interventional study: A study where researchers give a treatment and measure what happens.

References