Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sonesitatug vedotin · 2 trials · 4 indications
PFS is defined as time from randomisation until progression per RECIST 1.1, or death due to any cause, whichever occurs first.
OS is defined as the time from randomisation until the date of death due to any cause.
To assess the safety and tolerability of perioperative treatment.
pCR is defined as no viable cancer cells, including lymph nodes after complete evaluation in the resected gastric, GEJ, or esophageal cancer specimen and all sampled regional lymph nodes following neoadjuvant treatment.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Sonesitatug vedotin + Rilvegostomig + Capecitabine |
| Arm B | EXPERIMENTAL | Sonesitatug vedotin + Nivolumab + Capecitabine |
| Arm C | ACTIVE_COMPARATOR | Nivolumab + CAPOX OR Nivolumab + FOLFOX * nivolumab, capecitabine, oxaliplatin * nivolumab, 5-Fluorouracil, leucovorin, oxaliplatin |
| Arm D | EXPERIMENTAL | Sonesitatug vedotin + Capecitabine |
| Arm E | ACTIVE_COMPARATOR | Zolbetuximab + CAPOX or Zolbetuximab + FOLFOX: * zolbetuximab, capecitabine, oxaliplatin * zolbetuximab, 5-Fluorouracil, leucovorin, oxaliplatin CAPOX or FOLFOX: * oxaliplatin, capecitabine, * 5-Fluorouracil, leucovorin, oxaliplatin |
| Sub-study 1: Cohort 1a - Sonesitatug Vedotin plus Rilvegostomig and 5-FU or Capecitabine | EXPERIMENTAL | Participants will receive Sonesitatug Vedotin (Dose A) plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose A) plus Rilvegostomig as adjuvant therapy 2. |
| Sub-study 2: T-DXd plus Rilvegostomig and 5-FU or Capecitabine | EXPERIMENTAL | Participants will receive T-DXd plus Rilvegostomig and 5-FU or Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2. |
| Sub-study 3: Rilvegostomig plus FLOT chemotherapy | EXPERIMENTAL | Participants will receive Rilvegostomig plus FLOT chemotherapy as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Rilvegostomig as adjuvant therapy 2. |
| Sub-study 1: Cohort 1b - Sonesitatug Vedotin plus Rilvegostomig and Capecitabine | EXPERIMENTAL | Participants will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig and Capecitabine as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose B) plus Rilvegostomig as adjuvant therapy 2. |
| Sub-study 1: Cohort 1c - Sonesitatug Vedotin plus Rilvegostomig plus 5-FU and calcium folinate | EXPERIMENTAL | Participants will receive Sonesitatug Vedotin (Dose C) plus Rilvegostomig plus 5-FU and calcium folinate as neoadjuvant combination therapy (pre-surgery period) and adjuvant therapy 1 and later will receive Sonesitatug vedotin (Dose C) plus Rilvegostomig as adjuvant therapy 2. |
| Name | Type | Description |
|---|---|---|
| Sonesitatug vedotin | DRUG | Intravenous |
| Rilvegostomig | DRUG | Intravenous |
| Nivolumab | DRUG | Intravenous |
| Capecitabine | DRUG | Oral |
| 5-Fluorouracil | DRUG | Intravenous |
| Oxaliplatin | DRUG | Intravenous |
| Zolbetuximab | DRUG | Intravenous |
| Leucovorin | DRUG | Intravenous |
| Trastuzumab Deruxtecan (T-DXd) | DRUG | T-DXd will be administered as an IV infusion. |
| 5-Fluorouracil (5-FU) | DRUG | 5-FU (Fluoropyrimidine) will be administered as a continuous IV infusion as chemotherapy standard of care. |
| FLOT Chemotherapy | DRUG | FLOT (5-FU, leucovorin, oxaliplatin, and docetaxel) Chemotherapy will be administered as an IV infusion. |
| Calcium folinate | DRUG | Calcium folinate will be administered as an IV infusion as chemotherapy standard of care. |
Inclusion Criteria: * Capable of giving signed informed consent * Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent. * Previously untreated histologically documented unresectable, locally adva...
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Sonesitatug Vedotin is an investigational oncology drug being studied for the treatment of gastroesophageal adenocarcinoma and gastric cancer. It is being evaluated in clinical trials for patients with locally advanced resectable gastroesophageal adenocarcinoma and for those with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma expressing Claudin18.2.
Sonesitatug Vedotin targets Claudin18.2, a protein expressed in certain gastric and esophageal cancers. The drug is being studied specifically in patients whose tumors express Claudin18.2, as part of combination therapies for advanced or metastatic disease.
Sonesitatug Vedotin is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating gastroesophageal and gastric cancers.
Sonesitatug Vedotin is in Phase 2 and Phase 3 clinical development. It is being studied in a Phase 2 trial for perioperative treatment of locally advanced resectable gastroesophageal adenocarcinoma and in a Phase 3 trial for advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.
Sonesitatug Vedotin is being evaluated in two clinical trials. NCT07069712 is a Phase 2 study of novel agents as perioperative treatment in participants with locally advanced resectable gastroesophageal adenocarcinoma. NCT07431281 is a Phase 3 study of Sonesitatug Vedotin in combination with capecitabine, with or without rilvegostomig, in participants with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma expressing Claudin18.2.
Sonesitatug Vedotin is an investigational drug and no alternative names have been reported. It is being studied under its current name in clinical trials for the treatment of gastroesophageal and gastric cancers.