Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0901 · 3 trials · 4 indications
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 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 |
|---|---|---|
| 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 - 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 |
|---|---|---|
| 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) |
| 5-Fluorouracil | DRUG | Chemotherapy agents |
| Leucovorin | DRUG | Chemotherapy agents |
| l-leucovorin | DRUG | Chemotherapy agents |
| Nanoliposomal Irinotecan | DRUG | Chemotherapy agents |
| Gemcitabine | DRUG | Chemotherapy agents |
Inclusion Criteria: 1. Capable of giving signed informed consent prior to any study procedure. 2. Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF. 3. Histologically confirmed unresectable, locall...
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AZD0901 is an investigational small molecule being studied for the treatment of gastric cancer, including gastroesophageal junction adenocarcinoma. It is being evaluated in patients with advanced or metastatic disease that expresses Claudin18.2, typically as a second- or later-line therapy.
AZD0901 targets Claudin18.2, a protein expressed in certain gastric and gastroesophageal junction cancers. Clinical trials are specifically enrolling participants whose tumors express Claudin18.2, making it a key biomarker for patient selection in the ongoing studies.
AZD0901 is being developed by AstraZeneca PLC, a global biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in gastric cancer and other solid tumors.
AZD0901 is currently in Phase 3 clinical development. A Phase 3 trial is comparing it with investigator's choice of therapy in second- or later-line advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. Additional Phase 2 studies are also ongoing.
AZD0901 is being studied in three clinical trials. NCT06346392 is a Phase 3 trial in gastric and gastroesophageal junction cancer. NCT06219941 is a Phase 2 trial in advanced solid tumors including gastric, biliary tract, and pancreatic cancers. NCT07143604 is a Phase 2 trial in gastric and gastroesophageal junction adenocarcinoma.
AZD0901 is not FDA approved. It is an investigational drug currently in clinical development, with active trials in Phase 2 and Phase 3 stages. The drug has not yet completed the clinical trial process required for regulatory approval.