AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
Condition(s) studied
Investigational drug(s) / intervention(s)
AZD0901: Antibody-drug conjugate/Biologic
5-Fluorouracil: Chemotherapy agents
Leucovorin: Chemotherapy agents
l-leucovorin: Chemotherapy agents
Irinotecan: Chemotherapy agents
Nanoliposomal Irinotecan: Chemotherapy agents
Gemcitabine: Chemotherapy agents
Study summary
The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2 .
Eligibility
Primary outcome measure(s)
- Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs. — 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
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. - Objective Response Rate (ORR). — From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).
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.
Trial sites (52)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Orange | California | Recruiting |
| Research Site | Palo Alto | California | Recruiting |
| Research Site | Santa Rosa | California | Recruiting |
| Research Site | Louisville | Kentucky | Recruiting |
| Research Site | Commack | New York | Recruiting |
| Research Site | Providence | Rhode Island | Recruiting |
| Research Site | Houston | Texas | Recruiting |
| Research Site | Melbourne | Australia | Recruiting |
| Research Site | Murdoch | Australia | Recruiting |
| Research Site | Randwick | Australia | Recruiting |
| Research Site | Kingston | Ontario | Withdrawn |
| Research Site | Toronto | Ontario | Recruiting |
| Research Site | Montreal | Quebec | Recruiting |
| Research Site | Sherbrooke | Quebec | Recruiting |
| Research Site | Changsha | China | Not Yet Recruiting |
| Research Site | Chengdu | China | Not Yet Recruiting |
| Research Site | Tbilisi | Georgia | Recruiting |
| Research Site | Chūōku | Japan | Recruiting |
| Research Site | Kashiwa | Japan | Recruiting |
| Research Site | Kitaadachi-gun | Japan | Recruiting |
| Research Site | Kōtoku | Japan | Recruiting |
| Research Site | Nagoya | Japan | Recruiting |
| Research Site | Osakasayama-shi | Japan | Recruiting |
| Research Site | George Town | Malaysia | Recruiting |
| Research Site | Johor Bahru | Malaysia | Completed |
| Research Site | Kuala Lumpur | Malaysia | Recruiting |
| Research Site | Kuala Selangor | Malaysia | Recruiting |
| Research Site | Kuching | Malaysia | Recruiting |
| Research Site | Chisinau | Moldova | Recruiting |
| Research Site | Krakow | Poland | Recruiting |
| Research Site | Warsaw | Poland | Recruiting |
| Research Site | Bukit Merah | Singapore | Recruiting |
| Research Site | Singapore | Singapore | Recruiting |
| Research Site | Singapore | Singapore | Recruiting |
| Research Site | Singapore | Singapore | Recruiting |
| Research Site | Gyeonggi-do | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
| Research Site | Seoul | South Korea | Recruiting |
+ 12 more sites — see the full list on the official registry below.
More AstraZeneca trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06219941 on ClinicalTrials.gov ↗ ← All trials in the UK