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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06346392 | AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 | PHASE3 | ACTIVE NOT_RECRUITING | 592 | — | — | Mar 4, 2024 | Oct 14, 2026 | May 27, 2026 | 158 | United States, Brazil +17 |
| NCT07143604 | A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2 | PHASE2 | ACTIVE NOT_RECRUITING | 33 | — | — | Aug 29, 2025 | Sep 28, 2027 | Mar 17, 2026 | 13 | Russia |
| NCT06219941 | AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2 | PHASE2 | RECRUITING | 224 | — | — | Dec 13, 2023 | Sep 30, 2027 | Feb 12, 2026 | 52 | United States, Australia +12 |
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...