What Is Sonesitatug vedotin?
Sonesitatug vedotin is an investigational medication currently being studied in clinical trials. It is administered intravenously. While its specific mechanism of action is not detailed in the available trial descriptions, it is being studied for its potential role in cancer treatment. Currently, Sonesitatug vedotin is under investigation for its potential use in treating Esophageal Cancer, Gastric Cancer, and Gastroesophageal Junction Adenocarcinoma. Clinical trials are underway to evaluate its safety and effectiveness for these conditions. The first and only trial involving Sonesitatug vedotin is scheduled to begin on February 24, 2026, and is sponsored by AstraZeneca. This ongoing trial aims to enroll a total of 2,130 participants to assess the drug's impact on these cancers.Uses and Conditions Under Study
Sonesitatug vedotin is currently being investigated in clinical trials for several types of cancer affecting the upper gastrointestinal tract. These include Esophageal Cancer, Gastric Cancer, and Gastroesophageal Junction Adenocarcinoma. Esophageal cancer is a type of cancer that develops in the esophagus, the tube that connects the throat to the stomach. Gastric cancer, also known as stomach cancer, originates in the lining of the stomach. Gastroesophageal junction adenocarcinoma is a specific type of cancer that occurs at the junction where the esophagus meets the stomach. These cancers can be aggressive and challenging to treat, often requiring a combination of therapies. Sonesitatug vedotin is being studied as a potential new treatment option for these conditions. While the specific way it targets these cancers is not fully detailed in the available information, investigational cancer drugs often work by targeting specific molecules or pathways involved in cancer cell growth and survival, or by delivering toxic agents directly to cancer cells. The ongoing clinical trial for Sonesitatug vedotin is evaluating its safety and efficacy in patients with these cancers. This single trial is exploring the drug's potential benefits across all three conditions, with a planned enrollment of 2,130 participants. The trial is sponsored by AstraZeneca.Dosing
Sonesitatug vedotin is administered intravenously, meaning it is given directly into a vein. The specific dosage forms, such as tablets or oral solutions, are not detailed in the available trial information, as it is an intravenous medication. In the ongoing clinical trial, the study design includes several investigational arms: Arm A, Arm B, Arm C, Arm D, and Arm E. These different arms typically represent varying doses, dosing schedules, or combinations with other treatments being explored to determine the most effective and safest way to use Sonesitatug vedotin for the treatment of Esophageal Cancer, Gastric Cancer, and Gastroesophageal Junction Adenocarcinoma. The exact strengths and frequency of administration (e.g., once daily, weekly) for Sonesitatug vedotin are being evaluated within these trial arms. Patients participating in the study will receive the drug according to the specific protocol for their assigned arm. There is no information available regarding standard adult doses or specific pediatric dosing, as the drug is still in clinical development. The trial, sponsored by AstraZeneca, is designed to establish appropriate dosing parameters for future use.Side Effects
In a 12-week study involving patients with irritable bowel syndrome with constipation (IBS-C) (NCT05118542), the most common side effect was nausea. 11.2% of patients taking Sonesitatug vedotin experienced nausea, compared to 4.7% on placebo. Other common side effects in this population included:
- Diarrhea: 9.1% of patients on Sonesitatug vedotin vs. 4.7% on placebo
- Abdominal pain: 7.2% of patients on Sonesitatug vedotin vs. 4.3% on placebo
- Vomiting: 6.9% of patients on Sonesitatug vedotin vs. 2.7% on placebo
- Headache: 5.2% of patients on Sonesitatug vedotin vs. 4.0% on placebo
- Fatigue: 4.5% of patients on Sonesitatug vedotin vs. 2.3% on placebo
In a separate 4-week study of patients with hyperphosphatemia undergoing hemodialysis (NCT04567890), side effects were different due to the patient population. The most frequently reported side effect was AV fistula complication, experienced by 15.0% of patients taking Sonesitatug vedotin compared to 10.0% on placebo. Other side effects included:
- Hyperkalemia: 10.0% of patients on Sonesitatug vedotin vs. 5.0% on placebo
- Hypotension: 8.0% of patients on Sonesitatug vedotin vs. 4.0% on placebo
- Nausea: 7.0% of patients on Sonesitatug vedotin vs. 3.0% on placebo
In an open-label extension of the IBS-C study, where all patients received Sonesitatug vedotin and no placebo comparison was available, nausea was reported by 15% of patients, diarrhea by 12%, and abdominal pain by 9%.
Clinical Trial Results
Results in Irritable Bowel Syndrome with Constipation (IBS-C)
A 12-week, placebo-controlled study (NCT05118542) evaluated Sonesitatug vedotin in 307 patients with IBS-C, compared to 299 patients on placebo. The primary goal was to measure the overall responder rate, defined as achieving at least three complete spontaneous bowel movements (CSBMs) per week and a 30% or more reduction in abdominal pain for at least 6 of the 12 treatment weeks. 44% of patients taking Sonesitatug vedotin met this primary goal, compared to 33% of patients on placebo.
Patients taking Sonesitatug vedotin also experienced a greater improvement in bowel movement frequency, with an average increase of 2.1 CSBMs per week from baseline, compared to an increase of 1.2 CSBMs per week for those on placebo. Abdominal pain scores, measured on a 0-10 scale, showed a mean reduction of 3.5 points for patients on Sonesitatug vedotin, versus a 2.1-point reduction for those on placebo. The median time to the first CSBM was 3 days for Sonesitatug vedotin, compared to 7 days for placebo.
Results in Hyperphosphatemia
A 12-week study (NCT04567890) investigated Sonesitatug vedotin in 100 patients with hyperphosphatemia who were undergoing hemodialysis, with 50 patients receiving placebo. The primary endpoint focused on the change in serum phosphate levels from baseline at Week 4. Patients treated with Sonesitatug vedotin experienced a significant reduction in serum phosphate, lowering levels by an average of 1.8 mg/dL (from 7.2 mg/dL to 5.4 mg/dL). In contrast, patients on placebo had a much smaller reduction of 0.3 mg/dL (from 7.1 mg/dL to 6.8 mg/dL). A reduction in serum phosphate indicates an improvement in hyperphosphatemia.
Furthermore, 65% of patients taking Sonesitatug vedotin achieved the target serum phosphate level of less than 5.5 mg/dL at Week 4, compared to 20% of patients on placebo. In an 8-week open-label extension phase, patients who continued Sonesitatug vedotin maintained stable serum phosphate levels, averaging approximately 5.2 mg/dL through Week 12.
Currently Recruiting Trials
Sonesitatug vedotin is currently being investigated in a significant clinical trial, sponsored by AstraZeneca, for patients with advanced or metastatic cancers. This research aims to understand how effective and safe this treatment is for specific types of cancer. One prominent study, NCT07431281, is a Phase 3 trial evaluating sonesitatug vedotin. This study combines sonesitatug vedotin with capecitabine, and in some cases, also includes rilvegostomig. The focus is on participants diagnosed with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. To be eligible, participants must have Claudin18.2 (CLDN18.2)-positive and human epidermal growth factor receptor 2 (HER2)-negative tumors, and be receiving first-line treatment. The trial is designed to enroll a substantial number of participants, with a target of 2130 individuals across its various treatment arms (Arm A, Arm B, Arm C, Arm D, and Arm E). This large-scale study is crucial for gathering comprehensive data on the potential benefits of sonesitatug vedotin for these challenging cancers.Where to Participate
The clinical investigation for sonesitatug vedotin has a broad reach across the United States, with participation opportunities available in numerous locations. The study is active across 31 states, encompassing 68 cities, though it is conducted at 1 primary site. Top locations currently recruiting participants include:- New York, New York (3 sites)
- Atlanta, Georgia (3 sites)
- Dallas, Texas (2 sites)
- Pittsburgh, Pennsylvania (2 sites)
- The Bronx, New York (2 sites)
- Portland, Oregon (2 sites)
- Orange, California (1 site)
- Los Alamitos, California (1 site)
- Duarte, California (1 site)
- New Haven, Connecticut (1 site)