Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sonesitatug Vedotin, CMG901
AZD0901 · 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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AZD0901 is an investigational antibody-drug conjugate being studied for gastric cancer and gastroesophageal junction adenocarcinoma that express the biomarker Claudin18.2. It is also being evaluated in other advanced solid tumors expressing Claudin18.2, including biliary tract cancer and pancreatic ductal adenocarcinoma. It is not approved and remains in clinical development.
AZD0901 targets Claudin18.2, a tight junction protein expressed on gastric and gastroesophageal junction tumor cells. As an antibody-drug conjugate, it uses an antibody to bind Claudin18.2 and deliver a cytotoxic payload to those cells. Trials select patients whose tumors express Claudin18.2.
AZD0901 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsors the clinical program evaluating the antibody-drug conjugate in Claudin18.2-expressing gastric and gastroesophageal junction cancers and other solid tumors.
AZD0901 is in Phase 3 development. The Phase 3 trial NCT06346392 compares AZD0901 with investigator's choice of therapy in second- or later-line advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. Two additional Phase 2 trials are also ongoing. AZD0901 is investigational and has not been approved.
AZD0901 is being studied in three active trials. NCT06346392 is a Phase 3 trial in second- or later-line gastric or gastroesophageal junction adenocarcinoma. NCT07143604 is a Phase 2 monotherapy trial in 2L+ gastric or GEJ adenocarcinoma. NCT06219941 is a Phase 2 trial in advanced solid tumors expressing Claudin18.2.