Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07431281 | 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 | PHASE3 | RECRUITING | 2,130 | — | — | Feb 3, 2026 | Oct 27, 2031 | May 27, 2026 | 269 | United States, Australia +20 |
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.
| 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 |
| 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 |
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...