Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD0901
Sonesitatug Vedotin · 5 trials · 7 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.
The analysis will include all randomized participants. All events will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.
The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.
ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator per RECIST 1.1 to all dosed participants
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.
To investigate the safety and tolerability, of AZD0901 monotherapy or in combination with anti-cancer agents in particpants with advanced or metastatic solid tumours expressing CLDN18.2.
Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR) as determined by the Investigator at local site as per RECIST v1.1.
| 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 |
| AZD0901 arm 1 | EXPERIMENTAL | Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment. |
| AZD0901 Arm 2 | EXPERIMENTAL | Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed) |
| Investigator's choice arm | ACTIVE_COMPARATOR | Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies. |
| AZD0901 | EXPERIMENTAL | Participants will receive AZD0901 IV, Q3W |
| 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. |
| Sub Study 1 - AZD0901 MONOTHERAPY | EXPERIMENTAL | Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901. |
| Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA | EXPERIMENTAL | Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents |
| Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER | EXPERIMENTAL | Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR. |
| 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 |
| AZD0901 | DRUG | Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV |
| Ramucirumab+ paclitaxel | DRUG | Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W |
| Paclitaxel | DRUG | Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only) |
| Docetaxel | DRUG | Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only) |
| Irinotecan | DRUG | Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W |
| TAS-102 | DRUG | TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China) |
| Apatinib | DRUG | Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only) |
| 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. |
| l-leucovorin | DRUG | Chemotherapy agents |
| Nanoliposomal Irinotecan | DRUG | Chemotherapy agents |
| Gemcitabine | DRUG | Chemotherapy agents |
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 antibody-drug conjugate being studied for gastric cancer and gastroesophageal adenocarcinoma, including gastroesophageal junction and esophageal adenocarcinoma. It is being evaluated in patients with advanced or metastatic disease whose tumors express Claudin18.2, and in locally advanced resectable gastroesophageal adenocarcinoma in the perioperative setting.
Sonesitatug Vedotin is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the clinical trials evaluating the drug in gastric and gastroesophageal cancers.
Sonesitatug Vedotin is in Phase 3 clinical development. The Phase 3 trial is currently recruiting participants, and the drug has not been approved by the FDA. It remains an investigational agent in clinical development for gastric cancer and gastroesophageal adenocarcinoma.
Sonesitatug Vedotin is being evaluated in two recruiting clinical trials. The Phase 3 trial NCT07431281 is testing it in combination with capecitabine, with or without rilvegostomig, in advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma expressing Claudin18.2, with planned enrollment of 2,130 participants. The Phase 2 trial NCT07069712 is studying novel agents or combinations as perioperative treatment in locally advanced resectable gastroesophageal adenocarcinoma.
Sonesitatug Vedotin is an antibody-drug conjugate designed to target Claudin18.2, a protein expressed on certain gastric and gastroesophageal cancer cells. By binding to Claudin18.2, the conjugate delivers a cytotoxic payload to tumor cells. The Phase 3 trial enrolls patients whose tumors express Claudin18.2, reflecting this biomarker-selected mechanism.