In short
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.
Key points
- Sot102 is being studied in one completed Phase 1/2 clinical trial for advanced gastric, GEJ, and pancreatic adenocarcinoma. The trial looked at Sot102 given alone and with first-line standard treatment. In the early part of the study, researchers aimed to find the maximum tolerated dose and the recommended phase 2 dose. Later parts of the study assessed how well the treatment worked by measuring objective response rate. The trial enrolled 298 participants.
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.
This was an interventional study, which means the research team gave treatment and then measured the results.
The trial was in Phase 1/2, so it first focused on dose and safety, then on early signs of benefit.
Who was studied
The trial studied patients with advanced gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction (GEJ), and pancreatic adenocarcinoma.
These are cancer types that start in gland-like cells, and the GEJ is the area where the esophagus meets the stomach.
The study enrolled 298 people, showing that it was a fairly large early-phase cancer trial.
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.
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.
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.
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.
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.
The source data lists several standard treatment drugs used in the study, including folinic acid, Abraxane, oxaliplatin, OPDIVO, gemcitabine, and fluorouracil.
This design let researchers compare Sot102 alone with Sot102 plus standard treatment in different parts of the trial.
Trial status and size
The trial status is Completed, so the study has finished collecting data.
Because the study was completed and included 298 participants, it provided early information on both dose selection and tumor response in these cancer groups.
Patient glossary
Monotherapy means one treatment is used alone, without another cancer drug added.
Combination treatment means Sot102 was given together with other cancer medicines.
Clinical trial phase is the stage of research, and Phase 1/2 usually means the study is checking both safety and early benefit.
Enrollment is the number of people who joined the study.
Objective response rate is a standard way to measure whether tumors got smaller during treatment.